Guaifenesin and phenylephrine

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

There are many brands and forms of guaifenesin and phenylephrine available, and not all brands are included in this leaflet.

Guaifenesin and phenylephrine may also be used for reasons not mentioned in this medication guide.

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

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

Measure liquid medicine with the supplied measuring device (not a kitchen spoon).

Take the tablet 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 prescribed by your doctor.

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

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 phenylephrine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, and tranylcypromine.

Taking more than your recommended dose will not make guaifenesin and phenylephrine more effective, and may cause serious side effects.

Do not use guaifenesin and phenylephrine if you have taken an MAO inhibitor in the last 14 days. A dangerous drug interaction could happen. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, and tranylcypromine. Wait at least 14 days after stopping an MAO inhibitor before taking guaifenesin and phenylephrine.

Tell your doctor if you have or have ever had:

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

Ask your doctor before using this medicine if you are pregnant or breastfeeding.

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

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

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

• 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 FDA at 1-800-FDA-1088.

Usual Adult Dose for Cough and Nasal Congestion:

Dose referred to by strength of guaiFENesin/phenylephrine (in mg) per unit of measurement:Oral liquids:100/5 per 5 mL:10 mL every 4 hours, maximum 6 doses per dayOral tablets:385/10 per tablet: 1 tablet every 4 hours, maximum 6 doses per day388/10 per tablet: 1 tablet every 4 hours, maximum 6 doses per day395/10 per tablet: 1 tablet every 4 hours, maximum 6 doses per day

Usual Pediatric Dose for Cough and Nasal Congestion:

Dose referred to by strength of guaiFENesin/phenylephrine (in mg) per unit of measurement:Oral liquids:50/2.5 per 1 mL:2 to under 6 years: 1 mL every 4 hours, maximum 6 doses per day100/5 per 5 mL:12 years and older: 10 mL every 4 hours, maximum 6 doses per day6 to under 12 years: 5 mL every 4 hours, maximum 6 doses per dayOral tablets:385/10 per tablet:12 years and older: 1 tablet every 4 hours, maximum 6 doses per day6 to under 12 years: 1/2 tablet every 4 hours, maximum 6 doses per day388/10 per tablet: 12 years and older: 1 tablet every 4 hours, maximum 6 doses per day6 to under 12 years: 1/2 tablet every 4 hours, maximum 6 doses per day395/10 per tablet:12 years and older: 1 tablet every 4 hours, maximum 6 doses per day6 to under 12 years: 1/2 tablet every 4 hours, maximum 6 doses per day

Guaifenesin and phenylephrine 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 attention or call the Poison Help line at 1-800-222-1222.

Ask a doctor or pharmacist before taking other cough or cold medicines that may contain similar ingredients.

Ask a doctor or pharmacist before using any other medicines that can cause drowsiness (such as opioid medication, sleep medicine, a muscle relaxer, or medicine for anxiety or seizures). Tell your doctor about all other medicines you use. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.