Guaifenesin and pseudoephedrine

Guaifenesin and pseudoephedrine is a combination medicine used in adults and children to treat allergy symptoms like runny or stuffy nose, sneezing, watery eyes, itching of the nose and throat, cough with mucus, sinus pain, and to reduce chest congestion caused by the common cold, hay fever, or other allergies.

There are many brand forms of guaifenesin and pseudoephedrine available, and not all brands are mentioned in this leaflet.

Guaifenesin and pseudoephedrine may also be used for reasons not listed in this medication guide.

Use exactly as directed on the label, or as your doctor prescribes. Cold or cough medicine is only for short-term use.

Follow all instructions when giving guaifenesin and pseudoephedrine to a child. Do not use this medicine to make a child sleepy. Misuse of this medicine may cause death in very young children.

Taking more than your recommended dose will not make this medicine work better and may cause serious side effects.

Measure liquid medicine using the provided measuring device (not a kitchen spoon).

Swallow the extended release tablet whole and do not crush, chew, or break it. Take with a full glass of water.

Your dose may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using exactly as directed on the label, or as your doctor prescribes.

Stop using this medicine and call your doctor if your symptoms do not improve or get worse after 7 days, or if you also have a fever, rash, or headaches.

Store at room temperature away from moisture and heat.

Do not use guaifenesin and pseudoephedrine if you have taken an MAO inhibitor in the past 14 days. A dangerous interaction with the drug could happen. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, and tranylcypromine.

Taking more than the recommended dose will not make guaifenesin and pseudoephedrine work better and may lead to serious side effects.

Do not use guaifenesin and pseudoephedrine if you have taken an MAO inhibitor in the last 14 days. This could lead to a dangerous drug interaction. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, and tranylcypromine.

Tell your doctor if you have or have ever had:

• heart disease;
• high blood pressure;
• diabetes;
• a thyroid disorder;
• urination problems due to an enlarged prostate; or
• a cough with mucus or a chronic cough caused by smoking, asthma, chronic obstructive pulmonary disease (COPD), or another breathing disorder.

Tell your doctor if you are pregnant or breastfeeding.

Do not give this medicine to a child without medical advice.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Guaifenesin and pseudoephedrine may cause serious side effects. Stop using guaifenesin and pseudoephedrine and call your doctor right away if you have:

• nervousness, dizziness, sleep problems (insomnia).

This is not a complete list of side effects and others may happen. Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Dose for Cough and Nasal Congestion:

Immediate release tablets: 1 tablet orally every 4 hoursMaximum dose: 4 tablets per 24 hoursExtended release (600 mg/ 60 mg) tablets: 2 tablets orally every 12 hoursMaximum dose: 4 tablets per 24 hoursMaximum strength (1200 mg/ 120 mg) extended release tablets: 1 tablet orally every 12 hoursMaximum dose: 2 tablets per 24 hours

Usual Pediatric Dose for Cough and Nasal Congestion:

Immediate release tablets:12 years and older: 1 tablet orally every 4 hoursMaximum dose: 4 tablets per 24 hours6 to 12 years: One half tablet orally every 4 hoursMaximum dose: 2 tablets per 24 hoursExtended release (600 mg/ 60 mg) tablets: 12 years and older: 2 tablets orally every 12 hoursMaximum dose: 4 tablets per 24 hoursMaximum strength (1200 mg/ 120 mg) extended release tablets:12 years and older: 1 tablet orally every 12 hoursMaximum dose: 2 tablets per 24 hours25 mg/ 7.5 mg/ mL liquid: 2 to under 6 years (11 to 21 kg): 2 mL every 4 to 6 hoursMaximum dose: 4 doses per 24 hours

Guaifenesin and pseudoephedrine is used as needed. If you miss a dose while on a dosing schedule, skip it. Do not take two doses at the same time.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222.

Before taking other cough or cold medicines that may have similar ingredients, ask a doctor or pharmacist.

Ask a doctor or pharmacist before using any other medicines that can make you feel sleepy (like opioid medication, sleep medicine, a muscle relaxer, or medicine for anxiety or seizures). Inform your doctor about all other medicines you are taking. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are mentioned here.