promethazine/phenylephrine - oral
GENERIC NAME: PROMETHAZINE/PHENYLEPHRINE - ORAL (pro-METH-uh-zeen/fen-ill-EFF-rin)
WARNING: Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Some products (including some long-acting tablets/capsules) are not recommended for use in children younger than 12 years. Do not use this product to make a child sleepy.
This product is not recommended for use in children younger than 2 years since it might cause serious (possibly fatal) slow/shallow breathing. In children 2 years and older, carefully follow the doctor's directions to use the lowest effective dose. Do not give more often than prescribed. Talk to the doctor or pharmacist before giving other cough-and-cold medication that might contain the same or similar ingredients that might also affect breathing. Get immediate medical help if you notice unusual slow/shallow breathing.
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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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