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Acetaminophen / dextromethorphan / phenylephrine Pregnancy and Breastfeeding Warnings

Acetaminophen / dextromethorphan / phenylephrine is also known as: 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 Liquid Gels, BC Cough & Cold, 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, Mucinex Fast-Max Congestion & Headache, 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 ExpressMax Daytime Severe Cold & Cough, Theraflu Warming Relief Daytime Severe Cold & Cough, 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 Last updated on Oct 20, 2021.

Acetaminophen / dextromethorphan / phenylephrine Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy.

AU TGA pregnancy category: B2
US FDA pregnancy category: Not assigned

-Acetaminophen is commonly used during pregnancy and has been assumed safe; recent data questions the safety, especially with routine use or varying genetics.
-Routine use of acetaminophen during pregnancy is not advised.
-Available human data does not demonstrate major teratogenicity with dextromethorphan.
-Fetuses of mothers with slow dextromethorphan may be exposed to higher concentrations, but the clinical significance is unknown.
-According to some authorities dextromethorphan is compatible with pregnancy; low birth defect incidences were seen in surveillance studies.
-Phenylephrine is a sympathomimetic used in emergencies to treat hypotension and alleviate eye and ear allergic symptoms.
-Phenylephrine could cause constriction in uterine vessels (that are normally maximally dilated during pregnancy), reducing uterine blood flow, potentially causing fetal hypoxia.
-Phenylephrine may interact with oxytocic or ergot derivatives to cause persistent maternal hypertension; cerebral vessel rupture is possible.
-Sympathomimetic amines are teratogenic in some animal models, but are not suspected to cause human teratogenicity.

Animal studies are not available for the combination product. There are no controlled data in human pregnancy.

Acetaminophen: Routinely used during all stages of pregnancy, it appears safe for short-term use. This drug crosses the placenta.

Dextromethorphan: Available data does not indicate a major teratogenic risk, and a survey study did not show a relationship with congenital malformations.

Phenylephrine: A monitoring study including 1249 mother-child pairs that had first trimester phenylephrine exposure showed an increase in malformation, with association greater with minor defects than major defects (8 eye and ear defects, 6 syndactyly, 4 preauricular skin tags, and 3 clubfoot cases); 4149 any time pregnancy exposures were associated with 15 congenital dislocation of the hip, 6 umbilical hernia, and 4 other musculoskeletal defects. Placental transfer is likely with phenylephrine's low molecular weight (about 167).

AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Acetaminophen / dextromethorphan / phenylephrine Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Yes (acetaminophen) /Data not available (dextromethorphan, phenylephrine)
Excreted into animal milk: Data not available (dextromethorphan, phenylephrine)

-The amount of acetaminophen in breast milk is much less than typical infant doses.
-One study calculated that infants receive about 0.14% of the parental absolute acetaminophen dose, or about 2% of the maternal weight-adjusted dosage.
-Given dextromethorphan's low molecular weight, excretion into breastmilk is probable.
-Phenylephrine oral bioavailability is about 40%, making it unlikely an infant would receive large doses from breast milk.
-Phenylephrine may decrease milk production.

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:" ([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:" ([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.