Dextromethorphan, diphenhydramine, and phenylephrine

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

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

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.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken this medicine within the past few days.

Store at room temperature away from moisture and heat.

Since this 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.

Drinking alcohol can increase certain side effects of dextromethorphan, diphenhydramine, and phenylephrine.

Ask a doctor or pharmacist before using any other cold, cough, allergy, or sleep medicine. Antihistamines and cough suppressants are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine or cough suppressant.

This medication may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Get emergency medical help if you have any of these 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:

• confusion, severe anxiety, hallucinations, tremors;

• weak or shallow breathing;

• a light-headed feeling, like you might pass out;

• fast or pounding heartbeats;

• painful or difficult urination, little or no urinating;

• pale skin, weakness, easy bruising or bleeding, fever, chills, body aches; or

• increased blood pressure--severe headache, buzzing in your ears, chest pain, shortness of breath, uneven heartbeats.

Common side effects may include:

• dizziness, drowsiness, headache;

• constipation, upset stomach, loss of appetite;

• blurred vision, double vision, dry eyes;

• sleep problems (insomnia); or

• dry mouth, nose, or throat.

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.

Tell your doctor about all medicines you use, 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, diphenhydramine, and phenylephrine with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Dextromethorphan/diphenhydrAMINE/PE 15 mg-12.5 mg-15 mg/5 mL oral suspension, extended release: 5 to 10 mL orally every 12 hours.

Dextromethorphan/diphenhydrAMINE/PE 75 mg-25 mg-7.5 mg/5 mL oral suspension, extended release: 5 to 10 mL orally every 12 hours.

Dextromethorphan/diphenhydrAMINE/PE 15 mg-12.5 mg-15 mg/5 mL oral suspension, extended release:
2 to 5 years: 2.5 mL orally every 12 hours.
6 to 11 years: 5 mL orally every 12 hours.
12 years or older: 5 to 10 mL orally every 12 hours.

Dextromethorphan/diphenhydrAMINE/PE 75 mg-25 mg-7.5 mg/5 mL oral suspension, extended release
2 to 5 years: 1.25 to 2.5 mL orally every 12 hours.
6 to 11 years: 2.5 to 5 mL orally every 12 hours.
12 years or older: 5 to 10 mL orally every 12 hours.

Data not available