Tusnel

You should not use this medicine if you are allergic to dextromethorphan, guaifenesin, or pseudoephedrine.

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, phenelzine, rasagiline, selegiline, and tranylcypromine.

Ask a doctor or pharmacist if it is safe for you to take dextromethorphan, guaifenesin, and pseudoephedrine if you have:

• high blood pressure or coronary artery disease;

• diabetes;

• glaucoma;

• epilepsy or other seizure disorder;

• enlarged prostate or urination problems;

• pheochromocytoma (an adrenal gland tumor); or

• cough with mucus, or cough caused by emphysema or chronic bronchitis.

It is not known whether dextromethorphan, guaifenesin, and pseudoephedrine will harm an unborn baby. Ask a doctor before using this medicine if you are pregnant.

This medicine may pass into breast milk and may harm a nursing baby. Decongestants may also slow breast milk production. Ask a doctor before using this medicine if you are breast-feeding a baby.

Artificially sweetened cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.

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.

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

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food. Take with food if it causes an upset stomach.
• Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.

What do I do if I miss a dose?

• If you take Tusnel on a regular basis, take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• Many times this medicine is taken on an as needed basis. Do not take more often than told by the doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling sleepy.
• Feeling nervous and excitable.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

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

Dermatologic

Frequency not reported: Rash[Ref]

Nervous system

Frequency not reported: Nervousness, dizziness, insomnia, headache[Ref]

Other

Frequency not reported: Fever[Ref]

Respiratory

Frequency not reported: Cough, nasal congestion[Ref]

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