Fenesin DM IR

Do not use this medicine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, and tranylcypromine.

Do not give this medication to a child younger than 4 years old. 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.

Since this medicine is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

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

Stop using this medicine and call your doctor at once if you have:

• mood changes;

• severe headache; or

• severe dizziness or anxiety, feeling like you might pass out;.

Common side effects may include:

• dizziness, drowsiness;

• sleep problems (insomnia);

• diarrhea; or

• feeling nervous, restless, anxious, or irritable;.

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.

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

Applies to dextromethorphan / guaifenesin: oral capsule, oral liquid, oral packet, oral solution, oral syrup, oral tablet, oral tablet extended release 12 hour

Applies to dextromethorphan / guaifenesin: oral capsule, oral capsule extended release, oral elixir, oral granule, oral liquid, oral suspension extended release, oral tablet, oral tablet extended release

Nervous system

Nervous system side effects of dextromethorphan have included drowsiness and dizziness. Adverse effects, which have occurred at higher doses, include excitation, mental confusion, and opioid like respiratory depression. In some cases of abuse, patients have experienced euphoria, hyperactivity, mania, and auditory and visual hallucinations.[Ref]

Gastrointestinal

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

Dermatologic

Dermatologic side effects have included pruritus and rash.[Ref]

Hypersensitivity

Hypersensitivity side effects of dextromethorphan have included fixed-drug eruptions.[Ref]

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