benzydamine (oral rinse) (cont.)

HOW TO USE: This medication is a mouth rinse and/or gargle. It is not to be swallowed. Use this as directed. This may be diluted with equal amounts of water prior to rinsing or gargling if it causes irritation or burning. For mouth sores, place the prescribed amount in the mouth and try to keep the liquid in contact with the sores for at least 30 seconds before spitting it out. For a sore throat, gargle with the prescribed amount for at least 30 seconds before spitting it out.

SIDE EFFECTS: This may cause burning, stinging or numbness in the mouth or throat. Throat irritation, cough, dry mouth with thirst, and headache have also been reported. If any of these effects continue or become bothersome, inform your doctor. Notify your doctor if you experience: drowsiness, nausea or vomiting. If you notice other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS: Tell your doctor if you have: kidney problems, any allergies. This medication should be used only if clearly needed during pregnancy. Discuss the risks and benefits with your doctor. Because this medication may appear in breast milk, consult your doctor before breast-feeding.

DRUG INTERACTIONS: Tell your doctor of any over-the-counter or prescription medication you may take. Do not start or stop any medicine without doctor or pharmacist approval.

Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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