See also:
What is the most important information I should know about Sitrex?
Hypersensitivity to any component of product; hypersensitivity or idiosyncrasy to sympathomimetic amines, which may manifest by insomnia, dizziness, weakness, tremor, or arrhythmias. Phenylephrine (Sitrex) is contraindicated in patients with hypertension or ventricular tachycardia and should be employed only with extreme caution in elderly patients or in patients with hyperthyroidism, bradycardia, partial heart block, myocardial disease, or severe arteriosclerosis. Phenylephrine (Sitrex) is contraindicated in patents on monoamine oxidase (MAO) inhibitor therapy and for 14 days after stopping MAO therapy
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What are the possible side effects of Sitrex?
Nausea or headache may occur. If either of these effects persist or worsen, tell your doctor or pharmacist promptly.
If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if any of these unlikely but serious side effects occur: dizziness, fainting, shaking (tremor), fast/irregular/pounding heartbeat, difficult/painful urination, mental/mood changes (such as confusion, nervousness, irritability), trouble sleeping, seizures.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Temporary relief of symptoms of upper respiratory tract disorders such as sinusitis, vasomotor rhinitis, and hay fever; temporary relief of coughs associated with respiratory tract infections and related conditions such as sinusitis, pharyngitis, bronchitis, and asthma when tenacious mucus and/or mucus plugs and congestion complicate these conditions.
There are many brands and forms of Guaifenesin (Sitrex) and Phenylephrine (Sitrex) available and not all brands are listed on this leaflet.
Guaifenesin (Sitrex) is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.
Phenylephrine (Sitrex) is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).
Guaifenesin (Sitrex) and Phenylephrine (Sitrex) is a combination medicine used to treat stuffy nose and sinus congestion, and to reduce chest congestion caused by the common cold or flu.
Guaifenesin (Sitrex) and Phenylephrine (Sitrex) may also be used for purposes not listed in this medication guide.
Use Sitrex sustained-release tablets (12 hour) 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 Sitrex sustained-release tablets (12 hour).
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 combination medication is used to temporarily treat cough and runny/stuffy nose (nasal congestion) caused by infections (such as the common cold), allergies (such as hay fever), 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 (Sitrex) is an expectorant. It works by thinning and loosening mucus in the airways, clearing congestion, and making breathing easier. Phenylephrine (Sitrex) is a decongestant (sympathomimetic). It reduces nasal congestion by narrowing the blood vessels in the nose.
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 and may cause serious side effects. To decrease the risk for serious 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 SitrexTake this medication by mouth with or without food, as directed by your doctor. If you are self-treating, follow all directions on the product package. To prevent trouble sleeping, do not take this medication close to bedtime. If you are uncertain about any of the information, ask your doctor or pharmacist.
Dosage is based on your age, medical condition, and response to treatment. Do not increase your dose or take this drug more often than directed.
Guaifenesin (Sitrex) may have a bitter taste. Swallow capsules and tablets whole. Scored tablets may be split for lower doses. Chewable tablets may be swallowed whole or chewed.
Drink plenty of fluids while taking this medication. Fluids will help to break up mucus and clear congestion.
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. If your liquid form is a suspension, shake the bottle well before each dose.
Tell your doctor if your condition 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.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Liquid, oral:
Sitrex: Guaifenesin (Sitrex) 100 mg and Phenylephrine (Sitrex) hydrochloride 5 mg per 5 mL (480 mL) [dye free, ethanol free, sugar free; contains propylene glycol; orange flavor]
Mucinex Children's Stuffy Nose & Cold: Guaifenesin (Sitrex) 100 mg and Phenylephrine (Sitrex) hydrochloride 2.5 mg per 5 mL (118 mL) [contains edetate disodium, fd&c red #40, propylene glycol, and sodium benzoate; mixed berry flavor]
Nu-COPD: Guaifenesin (Sitrex) 200 mg and Phenylephrine (Sitrex) hydrochloride 10 mg per 5 mL (480 mL [DSC])
Rescon GG: Guaifenesin (Sitrex) 100 mg and Phenylephrine (Sitrex) hydrochloride 5 mg per 5 mL (120 mL [DSC], 480 mL [DSC]) [dye free, ethanol free; contains propylene glycol; wild cherry flavor]
Syrup, oral:
J-Max: Guaifenesin (Sitrex) 200 mg and Phenylephrine (Sitrex) hydrochloride 5 mg per 5 mL (473 mL [DSC]) [ethanol free, sugar free; contains propylene glycol; strawberry cream flavor]
Triaminic® Children's Chest & Nasal Congestion: Guaifenesin (Sitrex) 50 mg and Phenylephrine (Sitrex) hydrochloride 2.5 mg per 5 mL (118 mL) [contains benzoic acid, propylene glycol, sodium 3 mg/5 mL; tropical flavor]
Tablet, oral:
Ambi 10PEH/400GFN: Guaifenesin (Sitrex) 400 mg and Phenylephrine (Sitrex) hydrochloride 10 mg
Deconex IR: Guaifenesin (Sitrex) 385 mg and Phenylephrine (Sitrex) hydrochloride 10 mg [contains tartrazine]
Fenesin PE IR: Guaifenesin (Sitrex) 400 mg and Phenylephrine (Sitrex) hydrochloride 10 mg
Gcon IR: Guaifenesin (Sitrex) 385 mg and Phenylephrine (Sitrex) hydrochloride 10 mg
Medent®-PEI: Guaifenesin (Sitrex) 400 mg and Phenylephrine (Sitrex) hydrochloride 10 mg
MucaphEd: Guaifenesin (Sitrex) 400 mg and Phenylephrine (Sitrex) hydrochloride 10 mg [DSC]
Mucus Relief Sinus: Guaifenesin (Sitrex) 400 mg and Phenylephrine (Sitrex) hydrochloride 10 mg
Nu-COPD: Guaifenesin (Sitrex) 400 mg and Phenylephrine (Sitrex) hydrochloride 10 mg
OneTab™ Congestion & Cold: Guaifenesin (Sitrex) 400 mg and Phenylephrine (Sitrex) hydrochloride 10 mg
Refenesen™ PE: Guaifenesin (Sitrex) 400 mg and Phenylephrine (Sitrex) hydrochloride 10 mg
Relcof IR: Guaifenesin (Sitrex) 380 mg and Phenylephrine (Sitrex) hydrochloride 10 mg [DSC]
Sudafed PE® Non-Drying Sinus: Guaifenesin (Sitrex) 200 mg and Phenylephrine (Sitrex) hydrochloride 5 mg [DSC]
Dosing: Adult
Also refer to specific product labeling.
Expectorant/decongestant:
Oral:Liquid (Sitrex): Guaifenesin (Sitrex) 200 mg/Phenylephrine (Sitrex) 10 mg (10 mL) every 4 hours; maximum: Guaifenesin (Sitrex) 1,200 mg/Phenylephrine (Sitrex) 60 mg (60 mL)/24 hours
Tablet (Deconex IR): Guaifenesin (Sitrex) 385 mg/Phenylephrine (Sitrex) 10 mg (1 tablet) every 4 hours; maximum: 6 tablets/24 hours
Dosing: Geriatric
Refer to adult dosing.
Dosing: Pediatric
Cold/allergy symptoms: Note: Multiple concentrations of oral liquid formulations and solid oral dosage forms exist; close attention must be paid to the concentration when ordering or administering.
Liquid:
Guaifenesin (Sitrex) 100 mg and Phenylephrine (Sitrex) 2.5 mg per 5 mL (eg, Mucinex Children's Stuffy Nose and Cold):
Children ≥4 years to <6 years:
Oral: 5 mL every 4 hours; maximum daily dose: 30 mL/24 hours
Children ≥6 years to <12 years:
Oral: 10 mL every 4 hours; maximum daily dose: 60 mL/24 hours
Guaifenesin (Sitrex) 100 mg and Phenylephrine (Sitrex) 5 mg per 5 mL (eg, Sitrex):
Children ≥6 years to <12 years:
Oral: 5 mL every 4 hours; maximum daily dose: 30 mL/24 hours
Children ≥12 years and Adolescents:
Oral: 10 mL every 4 hours; maximum daily dose: 60 mL/24 hours
Tablet:
Guaifenesin (Sitrex) 385 mg and Phenylephrine (Sitrex) 10 mg per tablet (eg, Deconex IR):
Children ≥6 years to <12 years:
Oral: / tablet every 4 hours; maximum daily dose: 3 tablets/24 hours
Children ≥12 years and Adolescents:
Oral: 1 tablet every 4 hours; maximum daily dose: 6 tablets/24 hours
Guaifenesin (Sitrex) 400 mg and Phenylephrine (Sitrex) 10 mg per tablet (eg, Mucus Relief D): Children ≥12 years and Adolescents:
Oral: 1 tablet every 4 hours; maximum daily dose: 6 tablets/24 hours
See also:
What other drugs will affect Sitrex?
The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.
To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.
Some products that may interact with this drug include: other decongestants (taken by mouth or sprayed into the nose), tricyclic antidepressants (such as nortriptyline, amitriptyline), MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine).
Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking this medication.
Phenylephrine (Sitrex) may decrease the effectiveness of some blood pressure medications (such as beta blockers, reserpine, guanethidine, methyldopa, mecamylamine).
Guaifenesin (Sitrex) and Phenylephrine (Sitrex) are available in both prescription and nonprescription products. Check the labels of all your medications to make sure you are not taking more than one product containing Guaifenesin (Sitrex) or Phenylephrine (Sitrex).
Guaifenesin (Sitrex) can affect the results of certain lab tests (such as urine levels of certain acids). Make sure laboratory personnel and all your doctors know you use this drug.
This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
