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Acetaminophen / dextromethorphan / phenylephrine Pregnancy and Breastfeeding Warnings

Acetaminophen / dextromethorphan / phenylephrine is also known as: Alka-Seltzer Plus Maximum Strength Day & Night Cold & Flu Liquid Gels (Day Formula), Alka-Seltzer Plus Maximum Strength Day Cold & Flu Liquid Gels, Alka-Seltzer Plus Multi-Symptom Cold & Flu Day Liquid Gels, Alka-Seltzer Plus Severe Sinus Congestion & Cough (Day Formula), Alka-Seltzer Plus Severe Sinus Congestion & Cough Liquid Gels, Cold Multi-Symptom (Daytime), 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, Little Colds Multi-Symptom, Mapap Cold Formula, Multi Symptom Cold (Day Formula), Neocitran Non Drowsy Extra Strength Cold and Flu, Robitussin Cold + Flu (Daytime), Robitussin Peak Cold Daytime Cold + Flu, Theraflu Daytime Severe Cold & Cough, Theraflu Multi-Symptom Severe Cold with Lipton Flavors, Tylenol Cold Max Day, Tylenol Plus Children's Cold & Cough, Vicks Dayquil Cold & Flu Relief, Vicks Dayquil Cold & Flu Symptom Relief Plus Vitamin C, Vicks Nature Fusion Cold & Flu Multi-Symptom Relief

Medically reviewed by Drugs.com. Last updated on Oct 30, 2018.

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.

See references

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.

See references

References for pregnancy information

  1. "Product Information. Daytime (acetaminophen/dextromethorphan/PE)." Geiss, Destin & Dunn Inc, Peachtree City, GA.
  2. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee "Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregnancy. Available from: URL: http://www.tga.gov.au/docs/html/medpreg.htm." ([1999]):
  3. Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation. 10th ed." Philadelphia, PA: Wolters Kluwer Health (2015):

References for breastfeeding information

  1. "Product Information. Daytime (acetaminophen/dextromethorphan/PE)." Geiss, Destin & Dunn Inc, Peachtree City, GA.
  2. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  3. Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation. 10th ed." Philadelphia, PA: Wolters Kluwer Health (2015):

Further information

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

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