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Acetaminophen / dextromethorphan / pseudoephedrine Pregnancy and Breastfeeding Warnings

Acetaminophen / dextromethorphan / pseudoephedrine is also known as: Alka-Seltzer Plus Flu/Body, Comtrex Non-Drowsy, Contac Severe Cold and Flu Non Drowsy, Contact Cold and Sore Throat, Day Relief Cold and Flu, Day Time Multi Symptom, Daytime Cold, Daytime Cold and Flu Relief, Daytime Non-Drowsy, Non-Drowsy Super Strength Contac Complete, Severe Cold Multi-Symptom, Theraflu (pseudoephedrine) Daytime Severe Cold, Theraflu Flu Cold & Cough, Tylenol Cold Non-Drowsy Gelcaps, Vicks Dayquil Daytime Cold/Flu

Acetaminophen / dextromethorphan / pseudoephedrine Pregnancy Warnings

Acetaminophen/dextromethorphan/pseudoephedrine has not been formally assigned to a pregnancy category by the FDA. Acetaminophen has not been formally assigned to pregnancy category by the FDA. It is routinely used for short-term pain relief and fever in all stages of pregnancy. Acetaminophen is believed to be safe in pregnancy when used intermittently for short durations. Dextromethorphan has been assigned to pregnancy category C by the FDA. A teratogenic effect has been demonstrated in chicken embryos. There are no controlled data in human pregnancy. Pseudoephedrine has not been formally assigned to a pregnancy category by the FDA. Animal studies have not been reported. There are no controlled data in human pregnancy. Based on available data, pseudoephedrine is not thought to be teratogenic. Acetaminophen/dextromethorphan/pseudoephedrine is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.

Acetaminophen / dextromethorphan / pseudoephedrine Breastfeeding Warnings

There are no data on the excretion of acetaminophen/dextromethorphan/phenylephrine into human milk. Acetaminophen is excreted into human milk in small concentrations. One case of a rash has been reported in a nursing infant. Acetaminophen is considered compatible with breast-feeding by the American Academy of Pediatrics. There are no data on the excretion of dextromethorphan into human milk. Pseudoephedrine is excreted into human milk. The effects in the nursing infant are unknown. The American Academy of Pediatrics considers pseudoephedrine to be compatible with breast-feeding.

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