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Acetaminophen / dextromethorphan / diphenhydramine Pregnancy and Breastfeeding Warnings

Acetaminophen / dextromethorphan / diphenhydramine is also known as: Diabetic Tussin Night Time Cold & Flu, Diabetic Tussin Night Time Formula

Medically reviewed by Drugs.com. Last updated on Feb 11, 2019.

Acetaminophen / dextromethorphan / diphenhydramine Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned

Comments:
-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.
-According to some authorities diphenhydramine is compatible with pregnancy and may be the drug of choice if parenteral antihistamines are needed in pregnancy, however one case-controlled study showed association with cleft palate, and premature infants exposed within 2 weeks of birth risk toxicity.

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.

Diphenhydramine: Animal studies at doses up to 5 times the human dose showed no fetal toxicity or fertility impairment. Placental transfer was seen in sheep after a 100 mg intravenous dose with a fetal:maternal ratio of 0.85, peaking within 5 minutes. A monitoring study including 595 mother-child pairs that had first trimester diphenhydramine exposure showed no increase in major or minor malformations; 2948 any time pregnancy exposures showed no increase in major or minor malformations; unconfirmed possible associations include 3 hypospadia cases and 5 other genitourinary malformations, 3 eye and ear defects, 3 syndromes other than Down's, 13 inguinal hernias, 5 clubfoot cases, 5 diaphragm malformations, and 5 ventricular septal defects (any, opening or closing). A case control study of 599 first semester diphenhydramine exposures showed a statistical association with cleft palate; other studies have not found an association with cleft palate or have shown a decrease.


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 / diphenhydramine Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation.

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

Excreted into animal milk: Data not available (dextromethorphan)

Comments:
-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.
-One old biologic assay showed diphenhydramine in breast milk in some women after a 100 mg intramuscular dose; no studies using modern assays are available.
-According to some authorities, occasional, small diphenhydramine doses are not expected to adversely effect breastfeeding infants, but large or prolonged dosing may decrease the milk supply, especially in combination with a sympathomimetic amine (e.g. pseudoephedrine) or if lactation is not well established, and may have effects on the infant.
-Administering diphenhydramine after the last feeding of the day may minimize effects on the infant, but non-sedating antihistamines are preferred.

See references

References for pregnancy information

  1. 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 -]):
  2. "Product Information. Diabetic Tussin Night Time Formula (APAP/dextromethorphan/diphenhydramine)." Health Care Products, Amityville, NY.
  3. Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation. 10th ed." Philadelphia, PA: Wolters Kluwer Health (2015):

References for breastfeeding information

  1. Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation. 10th ed." Philadelphia, PA: Wolters Kluwer Health (2015):
  2. "Product Information. Diabetic Tussin Night Time Formula (APAP/dextromethorphan/diphenhydramine)." Health Care Products, Amityville, NY.

Further information

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

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