See also:
What is the most important information I should know about Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime)?
There are many brands and forms of Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) available and not all brands are listed on this leaflet.
Do not take more of this medication than is recommended. An overdose of Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) can damage your liver or cause death.
Know the amount of Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) in the specific product you are taking.
Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime).
Avoid drinking alcohol. It may increase your risk of liver damage while taking Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime).
Ask a doctor or pharmacist if it is safe for you to take this medicine if you have liver disease or a history of alcoholism.
Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) which can lead to a fatal overdose. Check the label to see if a medicine contains Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) or APAP.
See also:
What is the most important information I should know about Dextromethorphan (Zicam Multi-Symptom Cold and Flu Daytime)?
Do not use Dextromethorphan (Zicam Multi-Symptom Cold and Flu Daytime) if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take Dextromethorphan (Zicam Multi-Symptom Cold and Flu Daytime) before the MAO inhibitor has cleared from your body.
Do not use any other over-the-counter cough, cold, or allergy medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains Dextromethorphan (Zicam Multi-Symptom Cold and Flu Daytime).
See also:
What are the possible side effects of Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime)?
Applies to Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime): capsule, capsule liquid filled, elixir, liquid, powder, powder for solution, solution, suppository, suspension, syrup, tablet, tablet chewable, tablet disintegrating, tablet effervescent, tablet extended release
Other dosage forms:
Along with its needed effects, Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) (the active ingredient contained in Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime)) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime):
Rare
Get emergency help immediately if any of the following symptoms of overdose occur while taking Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime):
Symptoms of overdose
See also:
What are the possible side effects of Dextromethorphan (Zicam Multi-Symptom Cold and Flu Daytime)?
Applies to Dextromethorphan (Zicam Multi-Symptom Cold and Flu Daytime): oral capsule, oral capsule liquid filled, oral elixir, oral liquid, oral lozenge/troche, oral solution, oral suspension, oral suspension extended release, oral syrup, oral tablet
In addition to its needed effects, some unwanted effects may be caused by Dextromethorphan (Zicam Multi-Symptom Cold and Flu Daytime) (the active ingredient contained in Dextromethorphan (Zicam Multi-Symptom Cold and Flu Daytime) HBr Adult Formula). In the event that any of these side effects do occur, they may require medical attention.
Severity: ModerateIf any of the following side effects occur while taking Dextromethorphan (Zicam Multi-Symptom Cold and Flu Daytime), check with your doctor or nurse as soon as possible:
Symptoms of overdose:
Some of the side effects that can occur with Dextromethorphan (Zicam Multi-Symptom Cold and Flu Daytime) may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:
Less common or rare:
Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime)® (Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime)) injection is indicated for
used to treat symptoms caused by the common cold, flu, allergies, hay fever, or other breathing illnesses (e.g., sinusitis, bronchitis). Dextromethorphan (Zicam Multi-Symptom Cold and Flu Daytime) is a cough suppressant that affects a certain part of the brain (cough center), reducing the urge to cough. Decongestants help relieve stuffy nose symptoms. Antihistamines relieve watery eyes, itchy eyes/nose/throat, runny nose, and sneezing.
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, Guaifenesin (Zicam Multi-Symptom Cold and Flu Daytime) or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.Guaifenesin (Zicam Multi-Symptom Cold and Flu Daytime) and hydrocodone is used to treat cough and reduce chest congestion caused by the common cold, flu, or allergies.
Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) injection is used together with other medicines (eg, narcotic pain relievers) to relieve moderate to severe pain.
Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) is used to relieve mild to moderate pain and reduce fever in patients. It does not become habit-forming when taken for a long time. Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) may cause unwanted effects when taken in large doses, including liver damage.
Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) is available only with your doctor's prescription.
Dextromethorphan (Zicam Multi-Symptom Cold and Flu Daytime) is a cough suppressant. It affects the signals in the brain that trigger cough reflex.
Dextromethorphan (Zicam Multi-Symptom Cold and Flu Daytime) is used to treat a cough.
Dextromethorphan (Zicam Multi-Symptom Cold and Flu Daytime) will not treat a cough that is caused by smoking, asthma, or emphysema.
Dextromethorphan (Zicam Multi-Symptom Cold and Flu Daytime) may also be used for purposes not listed in this medication guide.
Guaifenesin (Zicam Multi-Symptom Cold and Flu Daytime) is used to reduce chest congestion caused by the common cold, flu, or chronic bronchitis.
Guaifenesin (Zicam Multi-Symptom Cold and Flu Daytime) helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.
There are many brands and forms of Guaifenesin (Zicam Multi-Symptom Cold and Flu Daytime) available. Not all brands are listed on this leaflet.
Guaifenesin (Zicam Multi-Symptom Cold and Flu Daytime) may also be used for purposes not listed in this medication guide.
Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) (with the Optizorb formulation) also contains the following excipients: Pregelatinized maize starch, calcium carbonate, alginic acid, crospovidone, povidone, magnesium stearate, colloidal anhydrous silica, parahydroxybenzoates (sodium methyl, ethyl and propyl), OPADRY YS-1-7003 white, carnauba wax, purified water.
It contains no sugar, lactose or gluten.
The d-isomer of the codeine analog of levorphanol. Dextromethorphan (Zicam Multi-Symptom Cold and Flu Daytime) shows high affinity binding to several regions of the brain, including the medullary cough center. This compound is an NMDA receptor antagonist (receptors, N-methyl-D-aspartate) and acts as a non-competitive channel blocker. It is one of the widely used antitussives, and is also used to study the involvement of glutamate receptors in neurotoxicity.
A synthetic opioid that is used as the hydrochloride. It is an opioid analgesic that is primarily a mu-opioid agonist. It has actions and uses similar to those of morphine. It also has a depressant action on the cough center and may be given to control intractable cough associated with terminal lung cancer. Guaifenesin (Zicam Multi-Symptom Cold and Flu Daytime) is also used as part of the treatment of dependence on opioid drugs, although prolonged use of methadone itself may result in dependence. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1082-3)
Use Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) injection as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) injection.
Use Dextromethorphan (Zicam Multi-Symptom Cold and Flu Daytime) orally disintegrating strips as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Dextromethorphan (Zicam Multi-Symptom Cold and Flu Daytime) orally disintegrating strips.
Use Guaifenesin (Zicam Multi-Symptom Cold and Flu Daytime) as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Guaifenesin (Zicam Multi-Symptom Cold and Flu Daytime).
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.This drug is used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever.
How to use Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) Extra StrengthTake this product by mouth as directed. Follow all directions on the product package. If you are uncertain about any of the information, consult your doctor or pharmacist.
There are many brands and forms of Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) available. Read the dosing instructions carefully for each product because the amount of Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) may be different between products. Do not take more Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) than recommended.
If you are giving Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) to a child, be sure you use a product that is meant for children. Use your child's weight to find the right dose on the product package. If you don't know your child's weight, you can use their age.
For suspensions, shake the medication well before each dose. Some liquids do not need to be shaken before use. Follow all directions on the product package. Measure the liquid medication with the provided dose-measuring spoon/dropper/syringe to make sure you have the correct dose. Do not use a household spoon.
For rapidly-dissolving tablets, chew or allow to dissolve on the tongue, then swallow with or without water. For chewable tablets, chew thoroughly before swallowing.
Do not crush or chew extended-release tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.
For effervescent tablets, dissolve the dose in the recommended amount of water, then drink.
Pain medications work best if they are used as the first signs of pain occur. If you wait until the symptoms have worsened, the medication may not work as well.
Do not take this medication for fever for more than 3 days unless directed by your doctor. For adults, do not take this product for pain for more than 10 days (5 days in children) unless directed by your doctor. If the child has a sore throat (especially with high fever, headache, or nausea/vomiting), consult the doctor promptly.
Tell your doctor if your condition persists or worsens or if you develop new symptoms. If you think you may have a serious medical problem, get medical help right away.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.This medication is used for temporary relief of coughs without phlegm that are caused by certain infections of the air passages (e.g., sinusitis, common cold). This product should not usually be used for an ongoing cough from smoking or long-term breathing problems (e.g., chronic bronchitis, emphysema) unless directed by your doctor. This product contains Dextromethorphan (Zicam Multi-Symptom Cold and Flu Daytime). It is a cough suppressant that works by decreasing the feeling of needing to cough.
Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Ask your doctor or pharmacist for more details about using your product safely.
These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Do not use this product to make a child sleepy. Do not give other cough-and-cold medication that might contain the same or similar ingredients. Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).
How to use Dextromethorphan (Zicam Multi-Symptom Cold and Flu Daytime)Take this medication by mouth, usually every 4 to 12 hours as needed or as directed by your doctor. If stomach upset occurs, take with food or milk. Use a medication-measuring device to measure your dose of liquid medication. Do not use a household spoon because you may not get the correct dose. If you are taking a suspension, shake the product well before measuring out your dose.
Dosage is based on the product you are taking and your age, medical condition, and response to treatment. If you are using this medication for self-treatment (without a prescription from your doctor), follow the specific dosing instructions on the packaging to find the correct dose for your age.
If your doctor directs you to take this medication daily, take it regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.
Improper use of this medication (abuse) may result in serious harm (e.g., brain damage, seizure, death). Do not increase your dose, take it more frequently, or use it for a longer time than prescribed. Properly stop the medication when so directed.
Tell your doctor if your symptoms persist or worsen after more than 1 week or if you also have fever, chills, headache, or rash. These may be signs of a more serious condition.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Guaifenesin (Zicam Multi-Symptom Cold and Flu Daytime) is used to treat coughs and congestion caused by the common cold, bronchitis, and other breathing illnesses. This product is usually not used for ongoing cough from smoking or long-term breathing problems (such as chronic bronchitis, emphysema) unless directed by your doctor. Guaifenesin (Zicam Multi-Symptom Cold and Flu Daytime) is an expectorant. It works by thinning and loosening mucus in the airways, clearing congestion, and making breathing easier.
If you are self-treating with this medication, it is important to read the package instructions carefully before you start using this product to be sure it is right for you.
Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Some products (such as long-acting tablets/capsules) are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely.
These products do not cure or shorten the length of the common cold. To decrease the risk for side effects, carefully follow all dosage directions. Do not give other cough-and-cold medication that might contain the same or similar ingredients. Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).
How to use 2/GTake this medication by mouth with or without food, as directed by your doctor, usually every 4 hours. If you are self-treating, follow all directions on the product package. If you are uncertain about any of the information, ask your doctor or pharmacist.
Guaifenesin (Zicam Multi-Symptom Cold and Flu Daytime) may have a bitter taste. Do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.
If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.
For powder packets, empty the entire contents of the packet onto the tongue and swallow. To prevent a bitter taste, do not chew.
Dosage is based on your age, medical condition, and response to treatment. Do not take more than 6 doses in a day. Do not increase your dose or take this drug more often than directed.
Drink plenty of fluids while taking this medication. Fluids will help to break up mucus and clear congestion.
Tell your doctor if your cough is accompanied by fever, severe sore throat, rash, persistent headache, or if it persists, returns, or worsens after 7 days. These may be signs of a serious medical problem. Seek immediate medical attention if you think you may have a serious medical problem.
Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) may be given as a single or repeated dose for the treatment of acute pain or fever. No dose adjustment is required when converting between oral Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) and Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) dosing in adults and adolescents who weigh 50 kg and above. Calculated maximum daily dose of Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) is based on all routes of administration (i.e., intravenous, oral, and rectal) and all products containing Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime). Exceeding the maximum mg/kg daily dose of Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) as described in Tables 1 and 2 may result in hepatic injury, including the risk of liver failure and death. To avoid the risk of overdose, ensure that the total amount of Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) from all routes and from all credits does not exceed the maximum recommended dose.
RecommendedDosage: Adults and Adolescents
Adults and adolescents weighing 50 kg and over: the recommended dosage of Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) is 1000 mg every 6 hours or 650 mg every 4 hours, with a maximum single dose of Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) of 1000 mg, a minimum dosing interval of 4 hours, and a maximum daily dose of Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) of 4000 mg per day (includes all routes of administration and all Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime)-containing products including combination products).
Adults and adolescents weighing under 50 kg: the recommended dosage of Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) is 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours, with a maximum single dose of Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) of 15 mg/kg, a minimum dosing interval of 4 hours, and a maximum daily dose of Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) of 75 mg/kg per day (includes all routes of administration and all Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime)-containing products including combination products).
Table 1: Dosing for Adults and Adolescents
| Age group | Dose given every 4 hours | Dose given every 6 hours | Maximum single dose | Maximum total daily dose of Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) (by all routes) |
| Adults and adolescents (13 years and older) weighing ≥ 50 kg | 650 mg | 1000 mg | 1000 mg | 4000 mg in 24 hours |
| Adults and adolescents (13 years and older) weighing < 50 kg | 12.5 mg/kg | 15 mg/kg | 15 mg/kg (up to 750 mg) | 75 mg/kg in 24 hours (up to 3750 mg) |
Dosage: Children
Children 2 to 12 years of age: the recommended dosage of Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) is 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours, with a maximum single dose of Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) of 15 mg/kg, a minimum dosing interval of 4 hours, and a maximum daily dose of Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) of 75 mg/kg per day.
Table 2: Dosing for Children
| Age group | Dose given every 4 hours | Dose given every 6 hours | Maximum single dose | Maximum total daily dose of Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) (by all routes) |
| Children 2 to 12 years of age | 12.5 mg/kg | 15 mg/kg | 15 mg/kg (up to 750 mg) | 75 mg/kg in 24 hours (up to 3750 mg) |
For adult and adolescent patients weighing ≥ 50 kg requiring 1000 mg doses of Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime), administer the dose by inserting a vented intravenous set through the septum of the 100 mL vial. Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) may be administered without further dilution. Examine the vial contents before dose preparation or administering. DO NOT USE if particulate matter or discoloration is observed. Administer the contents of the vial intravenously over 15-minutes. Use aseptic technique when preparing Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) for intravenous infusion. Do not add other medications to the Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) vial or infusion device.
For doses less than 1000 mg, the appropriate dose must be withdrawn from the vial and placed into a separate container prior to administration. Using aseptic technique, withdraw the appropriate dose (650 mg or weight-based) from an intact sealed Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) vial and place the measured dose in a separate empty, sterile container (e.g. glass bottle, plastic intravenous container, or syringe) for intravenous infusion to avoid the inadvertent delivery and administration of the total volume of the commercially available container. The entire 100 mL vial of Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) is not intended for use in patients weighing less than 50 kg. Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) is a single-use vial and the unused portion must be discarded.
Place small volume pediatric doses up to 60 mL in volume in a syringe and administer over 15 minutes using a syringe pump.
Monitor the end of the infusion in order to prevent the possibility of an air embolism, especially in cases where the Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) infusion is the primary infusion.
Once the vacuum seal of the glass vial has been penetrated, or the contents transferred to another container, administer the dose of Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) within 6 hours.
Do not add other medications to the Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) solution. Diazepam and chlorpromazine hydrochloride are physically incompatible with Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime), therefore do not administer simultaneously.
How suppliedDosage Forms And StrengthsAcetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) is a sterile, clear, colorless, non pyrogenic, preservative free, isotonic formulation of Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) intended for intravenous infusion. Each 100 mL glass vial contains 1000 mg Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) (10 mg/mL).
Storage And HandlingNDC 43825-102-01 - Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime)® (Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime)) Injection is supplied in a 100 mL glass vial containing 1000 mg Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) (10 mg/mL) in cartons of 24 vials.
Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) should be stored at 20°C to 25°C (68°F to 77°F).
For single use only. The product should be used within 6 hours after opening. Do not refrigerate or freeze.
Manufactured for: Mallinckrodt Hospital Products Inc., Hazelwood, MO 63042 USA. Revised: Dec 2014
Dosage FormsExcipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Capsule,
Oral, as hydrobromide:Robafen Cough: 15 mg [contains brilliant blue fcf (fd&c blue #1), fd&c red #40]
Robitussin Lingering CoughGels: 15 mg [contains brilliant blue fcf (fd&c blue #1), fd&c red #40, polyethylene glycol, propylene glycol]
Gel,
Oral, as hydrobromide:ElixSure Cough: 7.5 mg/5 mL (120 mL) [alcohol free; contains carbomer 934p, propylene glycol, propylparaben; cherry bubblegum flavor]
Liquid,
Oral, as hydrobromide:Buckleys Cough: 12.5 mg/5 mL (118 mL) [alcohol free, sugar free; contains butylparaben, menthol, propylparaben, saccharin sodium]
Little Colds Cough Formula: 7.5 mg/mL (30 mL) [alcohol free, dye free, saccharin free; contains sodium benzoate; grape flavor]
PediaCare Childrens Long-Act: 7.5 mg/5 mL (118 mL) [contains brilliant blue fcf (fd&c blue #1), saccharin sodium, sodium benzoate]
Robitussin Lingering LA Cough: 15 mg/5 mL (118 mL [DSC]) [contains alcohol, usp, fd&c red #40, menthol, saccharin sodium, sodium benzoate]
Dextromethorphan (Zicam Multi-Symptom Cold and Flu Daytime): 10 mg/5 mL (480 mL [DSC], 3780 mL [DSC]) [alcohol free, dye free, fructose free, sodium free, sorbitol free, sugar free]
Triaminic Long Acting Cough: 7.5 mg/5 mL (118 mL) [alcohol free, dye free, pseudoephedrine free; contains benzoic acid, propylene glycol]
Lozenge, Mouth/Throat, as hydrobromide:
Hold: 5 mg (10 ea)
Hold: 5 mg (10 ea) [cherry flavor]
Trocal Cough Suppressant: 7.5 mg (1 ea [DSC])
Strip,
Oral, as hydrobromide:Triaminic Long Acting Cough: 7.5 mg (14 ea, 16 ea) [contains alcohol, usp, fd&c red #40; cherry flavor]
Triaminic Long Acting Cough: 7.5 mg (14 ea) [contains alcohol, usp, fd&c red #40, isopropyl alcohol]
Suspension Extended Release,
Oral:Cough DM: Dextromethorphan (Zicam Multi-Symptom Cold and Flu Daytime) polistirex [equivalent to Dextromethorphan (Zicam Multi-Symptom Cold and Flu Daytime) hydrobromide 30 mg/5 mL] (89 mL) [alcohol free; contains fd&c yellow #10 aluminum lake, methylparaben, polysorbate 80, propylparaben, sodium metabisulfite; orange flavor]
Dextromethorphan (Zicam Multi-Symptom Cold and Flu Daytime): Dextromethorphan (Zicam Multi-Symptom Cold and Flu Daytime) polistirex [equivalent to Dextromethorphan (Zicam Multi-Symptom Cold and Flu Daytime) hydrobromide 30 mg/5 mL] (89 mL, 148 mL) [alcohol free; contains brilliant blue fcf (fd&c blue #1), disodium edta, methylparaben, polyethylene glycol, polysorbate 80, propylene glycol, propylparaben; grape flavor]
Dextromethorphan (Zicam Multi-Symptom Cold and Flu Daytime): Dextromethorphan (Zicam Multi-Symptom Cold and Flu Daytime) polistirex [equivalent to Dextromethorphan (Zicam Multi-Symptom Cold and Flu Daytime) hydrobromide 30 mg/5 mL] (89 mL, 148 mL) [alcohol free; contains edetate disodium, fd&c yellow #6 (sunset yellow), methylparaben, polyethylene glycol, polysorbate 80, propylene glycol, propylparaben; orange flavor]
Dextromethorphan (Zicam Multi-Symptom Cold and Flu Daytime) Cough Childrens: Dextromethorphan (Zicam Multi-Symptom Cold and Flu Daytime) polistirex [equivalent to Dextromethorphan (Zicam Multi-Symptom Cold and Flu Daytime) hydrobromide 30 mg/5 mL] (89 mL, 148 mL) [alcohol free; contains brilliant blue fcf (fd&c blue #1), edetate disodium, methylparaben, polyethylene glycol, polysorbate 80, propylene glycol, propylparaben, soybean oil; grape flavor]
Dextromethorphan (Zicam Multi-Symptom Cold and Flu Daytime) Cough Childrens: Dextromethorphan (Zicam Multi-Symptom Cold and Flu Daytime) polistirex [equivalent to Dextromethorphan (Zicam Multi-Symptom Cold and Flu Daytime) hydrobromide 30 mg/5 mL] (89 mL, 148 mL) [alcohol free; contains edetate disodium, fd&c yellow #6 (sunset yellow), methylparaben, polyethylene glycol, polysorbate 80, propylene glycol, propylparaben, soybean oil; orange flavor]
GoodSense Cough DM: Dextromethorphan (Zicam Multi-Symptom Cold and Flu Daytime) polistirex [equivalent to Dextromethorphan (Zicam Multi-Symptom Cold and Flu Daytime) hydrobromide 30 mg/5 mL] (148 mL) [alcohol free, gluten free; contains fd&c yellow #10 aluminum lake, methylparaben, polysorbate 80, propylparaben, sodium metabisulfite]
GoodSense Cough DM Childrens: Dextromethorphan (Zicam Multi-Symptom Cold and Flu Daytime) polistirex [equivalent to Dextromethorphan (Zicam Multi-Symptom Cold and Flu Daytime) hydrobromide 30 mg/5 mL] (89 mL, 148 mL) [alcohol free, gluten free; contains fd&c yellow #10 aluminum lake, methylparaben, polysorbate 80, propylparaben, sodium metabisulfite]
Robitussin 12 Hour Cough: Dextromethorphan (Zicam Multi-Symptom Cold and Flu Daytime) polistirex [equivalent to Dextromethorphan (Zicam Multi-Symptom Cold and Flu Daytime) hydrobromide 30 mg/5 mL] (89 mL) [alcohol free; contains brilliant blue fcf (fd&c blue #1), methylparaben, polysorbate 80, propylparaben, sodium metabisulfite]
Robitussin 12 Hour Cough: Dextromethorphan (Zicam Multi-Symptom Cold and Flu Daytime) polistirex [equivalent to Dextromethorphan (Zicam Multi-Symptom Cold and Flu Daytime) hydrobromide 30 mg/5 mL] (89 mL) [alcohol free; contains fd&c yellow #10 (quinoline yellow), methylparaben, polysorbate 80, propylparaben, sodium metabisulfite]
Robitussin 12 Hour Cough
Child: Dextromethorphan (Zicam Multi-Symptom Cold and Flu Daytime) polistirex [equivalent to Dextromethorphan (Zicam Multi-Symptom Cold and Flu Daytime) hydrobromide 30 mg/5 mL] (89 mL) [alcohol free; contains brilliant blue fcf (fd&c blue #1), methylparaben, polysorbate 80, propylparaben, sodium metabisulfite]
Generic: Dextromethorphan (Zicam Multi-Symptom Cold and Flu Daytime) polistirex [equivalent to Dextromethorphan (Zicam Multi-Symptom Cold and Flu Daytime) hydrobromide 30 mg/5 mL] (89 mL)
Syrup,
Oral, as hydrobromide:Creomulsion
Adult: 20 mg/15 mL (118 mL [DSC])
Creomulsion for Children: 5 mg/5 mL (118 mL [DSC]) [cherry flavor]
Robitussin Childrens Cough LA: 7.5 mg/5 mL (118 mL) [alcohol free; contains fd&c red #40, propylene glycol, saccharin sodium, sodium benzoate; fruit punch flavor]
Silphen DM Cough: 10 mg/5 mL (118 mL) [contains alcohol, usp; strawberry flavor]
Triaminic Long Acting Cough: 7.5 mg/5 mL (118 mL [DSC]) [alcohol free, dye free; contains benzoic acid, edetate disodium, propylene glycol]
Dosing: Adult
Cough suppressant:
Oral: 10 to 20 mg every 4 hours orDosing: Geriatric
Refer to adult dosing.
Dosing: Pediatric
Note: Safety and efficacy for the use of cough and cold products in infants and young children limited; the AAP warns against the use of these products for respiratory illnesses in infants and young children (AAP 2018; FDA 2017).
Cough suppressant:
Oral:Oral syrup (immediate release):Children 2 to <6 years: 5 mg every 4 hours as needed; do not exceed 6 doses in 24 hours.
Children 6 to <12 years: 10 mg every 4 hours as needed; do not exceed 6 doses in 24 hours.
Children ≥12 years and Adolescents: 20 mg every 4 hours as needed; do not exceed 6 doses in 24 hours.
Long-acting liquid: Children ≥12 years and Adolescents: 30 mg every 6 to 8 hours as needed; do not exceed 4 doses in 24 hours.
Oral capsule: Children ≥12 years and Adolescents: 30 mg every 6 to 8 hours as needed; do not exceed 4 doses in 24 hours.
Extended-release suspension (Dextromethorphan (Zicam Multi-Symptom Cold and Flu Daytime) polistirex):
Children 4 to <6 years: 15 mg every 12 hours as needed; do not exceed 30 mg in 24 hours.
Children 6 to <12 years: 30 mg every 12 hours as needed; do not exceed 60 mg in 24 hours.
Children ≥12 years and Adolescents: 60 mg every 12 hours as needed; do not exceed 120 mg in 24 hours.
ORGANIDIN® NR (Guaifenesin (Zicam Multi-Symptom Cold and Flu Daytime))Tablets — Adults and children 12 years of age and older: One to 2 tablets (200 mg to 400 mg) every four hours, not to exceed 2400 mg (12 tablets) in 24 hours.
PATIENTS SHOULD BE ADVISED TO KEEP THESE AND ALL DRUGS OUT OF THE REACH OF CHILDREN AND TO SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY IN CASE OF ACCIDENTAL OVERDOSE.
How suppliedORGANIDIN® NR (Guaifenesin (Zicam Multi-Symptom Cold and Flu Daytime))Tablets — Each round, scored, rose-colored tablet contains 200 mg Guaifenesin (Zicam Multi-Symptom Cold and Flu Daytime) USP—available in bottles of 100 (NDC 0037-4312-01)
StorageStore at controlled room temperature 20°-25°C (68°-77°F). Protect tablets from moisture. Keep bottle tightly closed.
To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-526-3840 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Meda Pharmaceuticals Inc. Somerset, New Jersey 08873-4120. Rev. 11/09
See also:
What other drugs will affect Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime)?
Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) is metabolized (eliminated by conversion to other chemicals) by the liver. Therefore drugs that increase the action of liver enzymes that metabolize Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) [for example, carbamazepine (Tegretol), isoniazid (INH, Nydrazid, Laniazid), rifampin (Rifamate, Rifadin, Rimactane)] reduce the levels of Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) and may decrease the action of Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime). Doses of Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) greater than the recommended doses are toxic to the liver and may result in severe liver damage. The potential for Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) to harm the liver is increased when it is combined with alcohol or drugs that also harm the liver.
Cholestyramine (Questran) reduces the effect of Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) by decreasing its absorption into the body from the intestine. Therefore, Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) should be administered 3 to 4 hours after cholestyramine or one hour before cholestyramine.
Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) doses greater than 2275 mg per day may increase the blood thinning effect of warfarin (Coumadin) by an unknown mechanism. Therefore, prolonged administration or large doses of Acetaminophen (Zicam Multi-Symptom Cold and Flu Daytime) should be avoided during warfarin therapy
See also:
What other drugs will affect Dextromethorphan (Zicam Multi-Symptom Cold and Flu Daytime)?
MAO inhibitors (including furazolidone, procarbazine, selegiline) when administered simultaneous with Dextromethorphan (Zicam Multi-Symptom Cold and Flu Daytime) may cause adrenergic crisis, collapse, coma, dizziness, agitation, increased blood pressure, hyperpyrexia, intracranial hemorrhage, lethargy, nausea, cramps, tremor. In combination with tricyclic antidepressants (amitriptyline, etc.) Dextromethorphan (Zicam Multi-Symptom Cold and Flu Daytime) Lafayette Pharmaceutical Laboratory may appeal serotonin syndrome and possible subsequent death. Amiodarone, fluoxetine, quinidine, inhibiting system cytochrome P450, may increase the drug concentration in the blood. Tobacco smoke can lead to increased secretion of glands in the background of inhibition of cough reflex. Some inhibitors of CYP450 (such as quinidine) increase and extended effects of this medicine.
See also:
What other drugs will affect Guaifenesin (Zicam Multi-Symptom Cold and Flu Daytime)?
In vitro results suggest that methadone undergoes hepatic N-demethylation by cytochrome P450 enzymes, principally CYP3A4, CYP2B6, CYP2C19 and to a lesser extent by CYP2C9 and CYP2D6. Coadministration of methadone with CYP inducers of these enzymes may result in a more rapid metabolism and potential for decreased effects of methadone, whereas administration with CYP inhibitors may reduce metabolism and potentiate methadones effects. Although antiretroviral drugs such as efavirenz, nelfinavir, nevirapine, ritonavir, lopinavir+ritonavir combination are known to inhibit CYPs, they are shown to reduce the plasma levels of methadone, possibly due to their CYP induction activity. Therefore, drugs administered concomitantly with methadone should be evaluated for interaction potential; clinicians are advised to evaluate individual response to drug therapy.
Opioid Antagonists, Mixed Agonist/Antagonists, and Partial Agonists
As with other mu-agonists, patients maintained on methadone may experience withdrawal symptoms when given opioid antagonists, mixed agonist/antagonists, and partial agonists. Examples of such agents are naloxone, naltrexone, pentazocine, nalbuphine, butorphanol, and buprenorphine.
Anti-retroviral Agents
Abacavir, amprenavir, efavirenz, nelfinavir, nevirapine, ritonavir, lopinavir+ritonavir combination - Coadministration of these anti-retroviral agents resulted in increased clearance or decreased plasma levels of methadone. Guaifenesin (Zicam Multi-Symptom Cold and Flu Daytime)-maintained patients beginning treatment with these antiretroviral drugs should be monitored for evidence of withdrawal effects and methadone dose should be adjusted accordingly.
Didanosine and Stavudine - Experimental evidence demonstrated that methadone decreased the AUC and peak levels for didanosine and stavudine, with a more significant decrease for didanosine. Guaifenesin (Zicam Multi-Symptom Cold and Flu Daytime) disposition was not substantially altered.
Zidovudine - Experimental evidence demonstrated that methadone increased the area under the concentration-time curve (AUC) of zidovudine which could result in toxic effects.
Cytochrome P450 Inducers
Guaifenesin (Zicam Multi-Symptom Cold and Flu Daytime)-maintained patients beginning treatment with CYP3A4 inducers should be monitored for evidence of withdrawal effects and methadone dose should be adjusted accordingly. The following drug interactions were reported following coadministration of methadone with inducers of cytochrome P450 enzymes:
Rifampin - In patients well-stabilized on methadone, concomitant administration of rifampin resulted in a marked reduction in serum methadone levels and a concurrent appearance of withdrawal symptoms.
Phenytoin - In a pharmacokinetic study with patients on methadone maintenance therapy, phenytoin administration (250 mg b.i.d. initially for 1 day followed by 300 mg QD for 3 to 4 days) resulted in an approximately 50% reduction in methadone exposure and withdrawal symptoms occurred concurrently. Upon discontinuation of phenytoin, the incidence of withdrawal symptoms decreased and methadone exposure increased to a level comparable to that prior to phenytoin administration.
St. Johns Wort, Phenobarbital, Carbamazepin/strong>Administration of methadone along with other CYP3A4 inducers may result in withdrawal symptoms.
Cytochrome P450 Inhibitors
Since the metabolism of methadone is mediated primarily by CYP3A4 isozyme, coadministration of drugs that inhibit CYP3A4 activity may cause decreased clearance of methadone. The expected clinical results would be increased or prolonged opioid effects. Thus, methadone-treated patients coadministered strong inhibitors of CYP3A4, such as azole antifungal agents (e.g., ketoconazole) and macrolide antibiotics (e.g., erythromycin), with methadone should be carefully monitored and dosage adjustment should be undertaken if warranted. Some selective serotonin reuptake inhibitors (SSRIs) (e.g., sertraline, fluvoxamine) may increase methadone plasma levels upon coadministration with methadone and result in increased opiate effects and/or toxicity.
Voriconazole - Repeat dose administration of oral voriconazole (400mg Q12h for 1 day, then 200mg Q12h for 4 days) increased the Cmax and AUC of (R)-methadone by 31% and 47%, respectively, in subjects receiving a methadone maintenance dose (30 to 100 mg QD). The Cmax and AUC of (S)-methadone increased by 65% and 103%, respectively. Increased plasma concentrations of methadone have been associated with toxicity including QT prolongation. Frequent monitoring for adverse events and toxicity related to methadone is recommended during coadministration. Dose reduction of methadone may be needed.
Others
Monoamine Oxidase (MAO) Inhibitors - Therapeutic doses of meperidine have precipitated severe reactions in patients concurrently receiving monoamine oxidase inhibitors or those who have received such agents within 14 days. Similar reactions thus far have not been reported with methadone. However, if the use of methadone is necessary in such patients, a sensitivity test should be performed in which repeated small, incremental doses of methadone are administered over the course of several hours while the patients condition and vital signs are under careful observation.
Desipramine - Blood levels of desipramine have increased with concurrent methadone administration.
Potentially Arrhythmogenic Agents
Extreme caution is necessary when any drug known to have the potential to prolong the QT interval is prescribed in conjunction with methadone. Pharmacodynamic interactions may occur with concomitant use of methadone and potentially arrhythmogenic agents such as class I and III antiarrhythmics, some neuroleptics and tricyclic antidepressants, and calcium channel blockers.
Caution should also be exercised when prescribing methadone concomitantly with drugs capable of inducing electrolyte disturbances (hypomagnesemia, hypokalemia) that may prolong the QT interval. These drugs include diuretics, laxatives, and, in rare cases, mineralocorticoid hormones.
Interactions with Alcohol and Drugs of Abuse
Guaifenesin (Zicam Multi-Symptom Cold and Flu Daytime) may be expected to have additive effects when used in conjunction with alcohol, other opioids or CNS depressants, or with illicit drugs that cause central nervous system depression. Deaths have been reported when methadone has been abused in conjunction with benzodiazepines.
Anxiety - Since methadone as used by tolerant patients at a constant maintenance dosage does not act as a tranquilizer, patients who are maintained on this drug will react to life problems and stresses with the same symptoms of anxiety as do other individuals. The physician should not confuse such symptoms with those of narcotic abstinence and should not attempt to treat anxiety by increasing the dose of methadone. The action of methadone in maintenance treatment is limited to the control of narcotic withdrawal symptoms and is ineffective for relief of general anxiety.
Acute Pain - Maintenance patients on a stable dose of methadone who experience physical trauma, postoperative pain or other acute pain cannot be expected to derive analgesia from their existing dose of methadone. Such patients should be administered analgesics, including opioids, in doses that would otherwise be indicated for non-methadone-treated patients with similar painful conditions. Due to the opioid tolerance induced by methadone, when opioids are required for management of acute pain in methadone patients, somewhat higher and/or more frequent doses will often be required than would be the case for non-tolerant patients.
Risk of Relapse in Patients on Guaifenesin (Zicam Multi-Symptom Cold and Flu Daytime) Maintenance Treatment of Opioid Addiction
Abrupt opioid discontinuation can lead to development of opioid withdrawal symptoms. Presentation of these symptoms have been associated with an increased risk of susceptible patients to relapse to illicit drug use and should be considered when assessing the risks and benefit of methadone use.
Tolerance and Physical Dependence
Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Physical dependence is manifested by withdrawal symptoms after abrupt discontinuation of a drug or upon administration of an antagonist. Physical dependence and/or tolerance are not unusual during chronic opioid therapy.
If methadone is abruptly discontinued in a physically dependent patient, an abstinence syndrome may occur. The opioid abstinence or withdrawal syndrome is characterized by some or all of the following: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate.
In general, chronically administered methadone should not be abruptly discontinued.
Special-Risk Patients
Guaifenesin (Zicam Multi-Symptom Cold and Flu Daytime) should be given with caution and the initial dose reduced in certain patients, such as the elderly and debilitated and those with severe impairment of hepatic or renal function, hypothyroidism, Addisons disease, prostatic hypertrophy, or urethral stricture. The usual precautions appropriate to the use of parenteral opioids should be observed and the possibility of respiratory depression should always be kept in mind.
Guaifenesin (Zicam Multi-Symptom Cold and Flu Daytime) side effectsSee also:
What are the possible side effects of Guaifenesin (Zicam Multi-Symptom Cold and Flu Daytime)?
Applies to Guaifenesin (Zicam Multi-Symptom Cold and Flu Daytime): oral capsule, oral capsule extended release, oral elixir, oral liquid, oral packet, oral solution, oral syrup, oral tablet, oral tablet extended release
In addition to its needed effects, some unwanted effects may be caused by Guaifenesin (Zicam Multi-Symptom Cold and Flu Daytime) (the active ingredient contained in Guaifenesin (Zicam Multi-Symptom Cold and Flu Daytime)). In the event that any of these side effects do occur, they may require medical attention.
Minor Side EffectsSome of the side effects that can occur with Guaifenesin (Zicam Multi-Symptom Cold and Flu Daytime) may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:
Less common or rare:
See also:
What is the most important information I should know about Guaifenesin (Zicam Multi-Symptom Cold and Flu Daytime)?
Guaifenesin (Zicam Multi-Symptom Cold and Flu Daytime) is contraindicated in patients with a known hypersensitivity to methadone hydrochloride or any other ingredient in DOLOPHINE.
Guaifenesin (Zicam Multi-Symptom Cold and Flu Daytime) is contraindicated in any situation where opioids are contraindicated such as: patients with respiratory depression (in the absence of resuscitative equipment or in unmonitored settings), and in patients with acute bronchial asthma or hypercarbia.
Guaifenesin (Zicam Multi-Symptom Cold and Flu Daytime) is contraindicated in any patient who has or is suspected of having a paralytic ileus.
