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Acetaminophen / dextromethorphan / doxylamine / phenylephrine Pregnancy and Breastfeeding Warnings

Acetaminophen / dextromethorphan / doxylamine / phenylephrine is also known as: Alka-Seltzer Plus Maximum Strength Day & Night Cold & Flu Liquid Gels (Night Formula), Alka-Seltzer Plus Maximum Strength Night Cold & Flu Liquid Gels, Alka-Seltzer Plus Multi-Symptom Cold & Flu (Night Formula), Alka-Seltzer Plus Multi-Symptom Cold & Flu Day & Night Liquid Gels (Night Formula), Alka-Seltzer Plus Night Cold Formula Liquid, Alka-Seltzer Plus Night Severe Cold+Flu Hot Drink Mix, Alka-Seltzer Plus Severe Sinus Congestion & Cough (Night Formula), Alka-Seltzer Plus Severe Sinus Congestion, Allergy & Cough Liquid Gels, Delsym Night Time Multi-Symptom, Mucinex Fast-Max Night Time Cold & Flu Liquid Gels, Tylenol Cold Multi-Symptom Nighttime Liquid, Vicks NyQuil Severe Cold & Flu

Medically reviewed on Sep 21, 2018

Acetaminophen / dextromethorphan / doxylamine / phenylephrine Pregnancy Warnings

Acetaminophen/dextromethorphan/doxylamine/phenylephrine 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. Animal studies have not been reported. There are no controlled data in human pregnancy.

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.

Doxylamine has been assigned to pregnancy category B by the FDA. Animal studies have not been reported. 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/doxylamine/phenylephrine is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.

See references

Acetaminophen / dextromethorphan / doxylamine / phenylephrine Breastfeeding Warnings

There are no data on the excretion of acetaminophen/dextromethorphan/doxylamine/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.

There are no data on the excretion of dextromethorphan into human milk.

There are no data on the excretion of doxylamine into human milk. However, other antihistamines are excreted into human milk in low concentrations.

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.

See references

References for pregnancy information

  1. "Product Information. Alka-Seltzer Plus Night-Time Cold (APAP/dextromethorphan/doxylamine/PE)." Bayer Pharmaceutical Inc, West Haven, CT.

References for breastfeeding information

  1. "Product Information. Alka-Seltzer Plus Night-Time Cold (APAP/dextromethorphan/doxylamine/PE)." Bayer Pharmaceutical Inc, West Haven, CT.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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