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Acetaminophen / diphenhydramine / phenylephrine Pregnancy and Breastfeeding Warnings

Acetaminophen / diphenhydramine / phenylephrine is also known as: Benadryl Allergy Plus Cold, Benadryl Severe Allergy Plus Sinus Headache, CVS Allergy & Cold, CVS Allergy & Sinus Headache, Children's Tylenol Plus Cold And Allergy, CounterAct Night, Delsym Children’s Cough+ Cold Night Time, Delsym Cough+ Cold Night Time, Equate Allergy & Sinus Headache, Mucinex Children's Night Time Multi-Symptom Cold, Mucinex Fast-Max Night Time Cold & Flu, Mucinex Sinus-Max Day & Night (Night), Mucinex Sinus-Max Night Time Congestion & Cough, Robitussin Multi-Symptom Cold Night Time, Robitussin Severe Multi-Symptom Cough Cold + Flu Nighttime, Severe Allergy and Sinus Headache, Sudafed PE Nighttime Cold, Sudafed PE Severe Cold, Suphedrine PE Severe Cold, Theraflu Nighttime Severe Cold & Cough, Theraflu Warming Relief Flu & Sore Throat, Theraflu Warming Relief Nighttime Severe Cold & Cough, Theraflu Warming Relief Sinus & Cold, Tylenol Allergy Multi-Symptom Nighttime, Tylenol Plus Children's Cold & Allergy

Acetaminophen / diphenhydramine / phenylephrine Pregnancy Warnings

Acetaminophen has not been formally assigned to a 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. Diphenhydramine has been assigned to pregnancy category B by the FDA. Animal studies have failed to reveal teratogenicity. The Collaborative Perinatal Project reported 595 first-trimester exposures and 2,948 exposures anytime during pregnancy. No relationship was found to large categories of malformations. Possible associations with individual malformation were found. One study reported a statistical relationship between diphenhydramine use in the first trimester and cleft palate. One case of withdrawal in an infant whose mother ingested 150 mg per day of diphenhydramine has been reported. This infant developed tremor on the fifth day of life which was treated with phenobarbital. 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/diphenhydramine/phenylephrine is only recommended for use during pregnancy when benefit outweighs risk.

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Acetaminophen / diphenhydramine / phenylephrine Breastfeeding Warnings

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. Diphenhydramine is excreted into human milk. Diphenhydramine may also inhibit lactation. 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. Tylenol Extra Strength PM (acetaminophen-diphenhydramine)." Johnson and Johnson/Merck Consumer, Fort Washington, PA.
  2. "Product Information. Lusonal (phenylephrine)." Wraser Pharmaceuticals, Ridgeland, MS.
  3. Parkin DE "Probable Benadryl withdrawal manifestations in a newborn infant." J Pediatr 85 (1974): 580
  4. Levy G, Garrettson LK, Soda DM "Evidence of placental transfer of acetaminophen." Pediatrics 55 (1975): 895
  5. Beaulac-Baillargeon L, Rocheleau S "Paracetamol pharmacokinetics during the first trimester of human pregnancy." Eur J Clin Pharmacol 46 (1994): 451-4
  6. Galinsky RE, Levy G "Absorption and metabolism of acetaminophen shortly before parturition." Drug Intell Clin Pharm 18 (1984): 977-9
  7. O'Brien WF, Krammer J, O'Leary TD, Mastrogiannis DS "The effect of acetaminophen on prostacyclin production in pregnant women." Am J Obstet Gynecol 168 (1993): 1164-9
  8. Zierler S, Purohit D "Prenatal antihistamine exposure and retrolental fibroplasia." Am J Epidemiol 123 (1986): 192-6
  9. Heinonen O, Slone D, Shapiro S; Kaufman DW ed. "Birth Defects and Drugs in Pregnancy." Littleton, MA: Publishing Sciences Group, Inc. (1977): 297
  10. Leathem AM "Safety and efficacy of antiemetics used to treat nausea and vomiting in pregnancy." Clin Pharm 5 (1986): 660-8
  11. Rudolph AM "Effects of aspirin and acetaminophen in pregnancy and in the newborn." Arch Intern Med 141 (1981): 358-63
  12. Brost BC, Scardo JA, Newman RB "Diphenhydramine overdose during pregnancy: lessons from the past." Am J Obstet Gynecol 175 (1996): 1376-7
  13. "Product Information. Sudafed PE Severe Cold (APAP/diphenhydramine/phenylephrine)." Pfizer U.S. Pharmaceuticals Group, New York, NY.

References for breastfeeding information

  1. Notarianni LJ, Oldham HG, Bennett PN "Passage of paracetamol into breast milk and its subsequent metabolism by the neonate." Br J Clin Pharmacol 24 (1987): 63-7
  2. Findlay JW, DeAngelis RL, Kearney MF, et al "Analgesic drugs in breast milk and plasma." Clin Pharmacol Ther 29 (1981): 625-33
  3. "Product Information. Lusonal (phenylephrine)." Wraser Pharmaceuticals, Ridgeland, MS.
  4. "Product Information. Tylenol Extra Strength PM (acetaminophen-diphenhydramine)." Johnson and Johnson/Merck Consumer, Fort Washington, PA.
  5. "Product Information. Sudafed PE Severe Cold (APAP/diphenhydramine/phenylephrine)." Pfizer U.S. Pharmaceuticals Group, New York, NY.
  6. Roberts RJ, Blumer JL, Gorman RL, et al "American Academy of Pediatrics Committee on Drugs: Transfer of drugs and other chemicals into human milk." Pediatrics 84 (1989): 924-36
  7. Committee on Drugs, 1992 to 1993 "The transfer of drugs and other chemicals into human milk." Pediatrics 93 (1994): 137-50

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