Guaifenesin

Guaifenesin is an ingredient in cough and cold medicines that is used to help clear mucus or phlegm from your chest when you have had a cold or flu. Guaifenesin works by making your mucus thinner and easier to cough up, which helps clear chest congestion. Guaifenesin is available as an over-the-counter (OTC) medicine and also available on prescription.

Guaifenesin is not FDA approved for treatment of fibromyalgia but some people take it off-label for this condition. In clinical studies guaifenesin has not shown to be effective for fibromyalgia.

Use guaifenesin exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cough medicine is usually taken only for a short time until your symptoms clear up.

Take guaifenesin with food if it upsets your stomach.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Do not crush, chew, break, or open a controlled-release, delayed-release, or extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication.

Stop using this medicine and ask a doctor if your cough lasts more than 7 days, comes back, or occurs with a fever, rash, or persistent headache. These could be signs of a serious illness.

Store at room temperature away from moisture, heat, and light.

You should not use this medicine if you are allergic to guaifenesin.

Use this medicine exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.

Guaifenesin is commonly found as part of over-the-counter combination medications for cold and cough. Read labels or ask a doctor or pharmacist before using any other cold, or cough medicine when taking guaifenesin.

Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication. This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have other medical conditions, such as liver disease, kidney disease, phenylketonuria (PKU), a persistent or chronic cough (such as from smoking, asthma, chronic bronchitis, or emphysema), or a cough with too much mucus.

It is not known whether guaifenesin will harm an unborn baby. Ask a doctor before using this medicine if you are pregnant.

It is not known whether guaifenesin passes into breast milk or if it could harm a nursing baby. Ask a doctor before using this medicine if you are breast-feeding a baby.

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

Tell your doctor if you are taking this medicine before you have any medical tests. Guaifenesin may affect the results of certain lab tests.

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

Common guaifenesin side effects may include:

• dizziness, headache;
• drowsiness;
• rash; or
• nausea, vomiting, stomach upset.

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

Usual Adult Dose for Cough:

Immediate release formulation: 200 to 400 mg orally every 4 hours as needed, not to exceed 2.4 g/day Sustained release formulation: 600 to 1200 mg orally every 12 hours, not to exceed 2.4 g/day

Usual Pediatric Dose for Cough:

Immediate release formulation: less than 2 years: 12 mg/kg/day orally in 6 divided doses 2 to 5 years: 50 to 100 mg orally every 4 hours as needed, not to exceed 600 mg/day 6 to 11 years: 100 to 200 mg orally every 4 hours as needed, not to exceed 1.2 g/day 12 years or older: 200 to 400 mg orally every 4 hours as needed, not to exceed 2.4 g/day Sustained release formulation: 2 to 5 years: 300 mg orally every 12 hours, not to exceed 600 mg/day 6 to 11 years: 600 mg orally every 12 hours, not to exceed 1.2 g/day 12 years or older: 600 to 1200 mg orally every 12 hours, not to exceed 2.4 g/day

Since cough or cold medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

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

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Ask a doctor or pharmacist before using any other cold, or cough medicine. Many combination medicines contain guaifenesin. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains guaifenesin.

Other drugs may interact with guaifenesin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.