Donatussin Drops

There are many brands and forms of guaifenesin and phenylephrine available and not all brands are listed on this leaflet.

Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.

Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Guaifenesin and phenylephrine 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 and phenylephrine may also be used for purposes not listed in this medication guide.

Use 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 or cold medicine is usually taken only for a short time until your symptoms clear up.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children.

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 an extended-release tablet or capsule. Swallow it whole.

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

Call your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

Store at room temperature away from moisture and heat.

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

Ask a doctor or pharmacist before using this medicine if you are also using any other drugs, including prescription and over-the-counter medicines, vitamins, and herbal products. Some medicines can cause unwanted or dangerous effects when used together. Not all possible interactions are listed in this medication guide.

Taking this medicine with other drugs that make you sleepy or slow your breathing can worsen these effects. Ask your doctor before taking guaifenesin and phenylephrine with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Applies to guaifenesin / phenylephrine: oral capsule, oral capsule extended release, oral drops, oral liquid, oral suspension, oral syrup, oral tablet, oral tablet extended release

Cardiovascular

Cardiovascular side effects have included tachycardia, palpitations, arrhythmias, and cardiovascular collapse with hypotension.[Ref]

Nervous system

Nervous system side effects have included central nervous system depression, tremor, headache, dizziness, restlessness, insomnia, and convulsions.[Ref]

Psychiatric

Psychiatric side effects have included fear, nervousness, anxiety, and hallucinations.[Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea and vomiting.[Ref]

Respiratory

Respiratory side effects have included breathing difficulty.[Ref]

Genitourinary

Genitourinary side effects have included dysuria.[Ref]

Dermatologic

Dermatologic side effects have included pallor.[Ref]

General

General side effects have included weakness.[Ref]

Some side effects of Donatussin Drops may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.