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Acetaminophen / dextromethorphan / phenylephrine Pregnancy and Breastfeeding Warnings

Acetaminophen / dextromethorphan / phenylephrine is also known as: Alka-Seltzer Plus Day & Night Cold Formula (Day Cold) Liquid Gels, Alka-Seltzer Plus Day Non-Drowsy Cold Formula Liquid Gels, Alka-Seltzer Plus Multi-Symptom Cold & Flu (Day Formula), Alka-Seltzer Plus Severe Sinus Congestion & Cough (Day Formula), Comtrex Cold & Cough, Comtrex Cold and Cough Maximum Strength, Contac Complete Cough, Cold & Flu Extra Strength, Day Relief PE, Day Time Multi-Symptom Cold/Flu Relief, Daytime Cold & Flu, Flu & Severe Cold & Cough Daytime Powder, Little Colds Multi-Symptom, Mapap Cold Formula, Multi Symptom Cold (Day Formula), Neocitran Non Drowsy Extra Strength Cold and Flu, Robitussin Peak Cold Daytime Cold + Flu, Theraflu Daytime Severe Cold & Cough, Theraflu Multi-Symptom Severe Cold, Theraflu Warming Relief Caplets Daytime Multi-Symptom Cold, Theraflu Warming Relief Daytime Severe Cough & Cold, Tylenol Cold Head Congestion Daytime, Tylenol Cold Multi-Symptom Daytime, Tylenol Plus Children's Cold & Cough, Vicks Dayquil Cold & Flu Relief, Vicks Dayquil Cold & Flu Symptom Relief Plus Vitamin C

Acetaminophen / dextromethorphan / phenylephrine Pregnancy Warnings

Acetaminophen/dextromethorphan/phenylephrine has not been 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. Phenylephrine has been assigned to pregnancy category C by the FDA. Animal studies have not been reported. There are no controlled data in human pregnancy. Acetaminophen/dextromethorphan/phenylephrine is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.

Acetaminophen / dextromethorphan / phenylephrine 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. Small amounts of phenylephrine are secreted in breast milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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