Ambifed-G

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.

The chewable tablet must be chewed before you swallow it.

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 pseudoephedrine with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Applies to guaifenesin / pseudoephedrine: oral capsule, oral liquid, oral syrup, oral tablet, oral tablet extended release 12 hour

Applies to guaifenesin / pseudoephedrine: oral capsule, oral capsule extended release, oral liquid, oral syrup, oral tablet, oral tablet chewable, oral tablet extended release

Cardiovascular

Cardiovascular side effects have included significant increases in heart rate. Hypertension and arrhythmias have also been problematic in susceptible patients.[Ref]

Pseudoephedrine may cause vasoconstriction which generally does not produce hypertension, but may be problematic for patients with preexisting hypertension. Arrhythmias may be produced in predisposed patients. Rarely, pseudoephedrine has been reported to cause coronary artery spasm and chest pain.[Ref]

Nervous system

Nervous system side effects of pseudoephedrine have included stimulation, resulting in tremor, anxiety, and nervousness. Insomnia has been reported in up to 30% of pseudoephedrine-treated patients. Headache has also been reported in patients receiving pseudoephedrine. Guaifenesin has occasionally caused dizziness and headache.[Ref]

Gastrointestinal

Gastrointestinal side effects associated with pseudoephedrine have included anorexia and gastric irritation in approximately 5% of patients. Dry mouth, nose, or throat has occurred in up to 15% of patients. Gastrointestinal upset and vomiting have been reported with higher than recommended doses of guaifenesin. Doses recommended for expectoration have rarely been associated with gastrointestinal upset.[Ref]

Hypersensitivity

Hypersensitivity side effects have included fixed drug eruptions secondary to pseudoephedrine.[Ref]

Dermatologic

Dermatologic side effects have included rare reports of rash.[Ref]

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

The FDA has not approved use of over-the-counter cough and cold medications to children aged less than 2 years, and proper dosing for children in this age group has not been studied. Clinicians should be aware of the risk for serious illness or fatal overdose from administration of cough and cold medications to children aged less than 2 years. Clinicians should be certain that caregivers understand 1) the importance of administering cough and cold medications only as directed and 2) the risk for overdose if they administer additional medications that might contain the same ingredient.

There are no data on the excretion of guaifenesin into human milk. Pseudoephedrine is excreted into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Three mothers given pseudoephedrine demonstrated milk concentrations consistently higher than plasma concentrations. Maximum milk concentrations were reached at 1 to 1.5 hours after dosing. In one woman, the milk:plasma concentration ratio at 1, 3, and 12 hours was 3.3, 3.9, and 2.6, respectively. The authors calculated that 1000 mL of breast milk consumed over 24 hours would provide an infant with 0.25 to 0.33 mg of pseudoephedrine, or 0.5% to 0.7% of the dose ingested by the mother.