Safetussin DM

• Kramer Laboratories, Inc.

Safetussin DM is part of the drug classes:

• Opium alkaloids and derivatives

• Expectorants

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.

Ask a doctor or pharmacist if it is safe for you to take this medication if you have emphysema or chronic bronchitis.

It is not known whether dextromethorphan and guaifenesin will harm an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant.

It is not known whether dextromethorphan and guaifenesin passes into breast milk or if it could harm a nursing baby. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

Artificially sweetened liquid medicine may contain phenylalanine. Check the medication label if you have phenylketonuria (PKU).

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol can increase certain side effects of this medicine.

Ask a doctor or pharmacist before using any cough, cold, or allergy medicine. Many medicines available over the counter contain dextromethorphan or guaifenesin. Taking certain products together can cause you to get too much of this type of medication. Check the label to see if a medicine contains an antitussive or expectorant.

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

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 you have any side effects that bother you or do not go away.

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.