Benylin DM Pediatric

Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.

Dextromethorphan is used to treat a cough.

Dextromethorphan will not treat a cough that is caused by smoking, asthma, or emphysema.

Dextromethorphan may also be used for purposes not listed in this medication guide.

There are many brands and forms of dextromethorphan available. Not all brands are listed on this leaflet.

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

Do not give this medicine to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child of any age. Death can occur from the misuse of cough and cold medicines 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.

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

Talk with 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.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cough medicine within the past few days.

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

Since cough medicine is usually taken only as 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. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

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

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

• severe dizziness, anxiety, restless feeling, or nervousness;

• confusion, hallucinations; or

• slow, shallow breathing.

Common side effects may include 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.

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

Applies to dextromethorphan: compounding powder, oral capsule, oral disintegrating strip, oral drops, oral liquid, oral lozenge, oral solution, oral suspension extended release, oral syrup, oral tablet chewable

General

Adverse effects have included gastrointestinal disturbances such as stomach upset and diarrhea.[Ref]

Nervous system

Frequency not reported: Drowsiness, dizziness, convulsions[Ref]

Respiratory

Frequency not reported: Respiratory depression[Ref]

Gastrointestinal

Frequency not reported: Vomiting, nausea, diarrhea, abdominal pain, gastrointestinal disturbance[Ref]

Hypersensitivity

Rare (less than 0.1%): Fixed-drug eruptions[Ref]

Psychiatric

Cases of abuse have been reported.[Ref]

Frequency not reported: Mental confusion, excitation, insomnia, abuse[Ref]

Dermatologic

Frequency not reported: Rash, angioedema, pruritus, urticaria[Ref]

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