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Acetaminophen / dextromethorphan / pseudoephedrine Pregnancy and Breastfeeding Warnings

Acetaminophen / dextromethorphan / pseudoephedrine is also known as: Alka-Seltzer Plus Flu/Body, Comtrex Non-Drowsy, Contac Severe Cold and Flu Non Drowsy, Contact Cold and Sore Throat, Day Relief Cold and Flu, Day Time Multi Symptom, Daytime Cold, Daytime Cold and Flu Relief, Daytime Non-Drowsy, Non-Drowsy Super Strength Contac Complete, Severe Cold Multi-Symptom, Theraflu (pseudoephedrine) Daytime Severe Cold, Theraflu Flu Cold & Cough, Tylenol Cold Non-Drowsy Gelcaps, Vicks Dayquil Daytime Cold/Flu

Acetaminophen / dextromethorphan / pseudoephedrine Pregnancy Warnings

Acetaminophen/dextromethorphan/pseudoephedrine 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. 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. Pseudoephedrine has not been formally assigned to a pregnancy category by the FDA. Animal studies have not been reported. There are no controlled data in human pregnancy. Based on available data, pseudoephedrine is not thought to be teratogenic. Acetaminophen/dextromethorphan/pseudoephedrine is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.

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Acetaminophen / dextromethorphan / pseudoephedrine 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. Pseudoephedrine is excreted into human milk. The effects in the nursing infant are unknown. The American Academy of Pediatrics considers pseudoephedrine to be compatible with breast-feeding.

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References for pregnancy information

  1. Beaulac-Baillargeon L, Rocheleau S "Paracetamol pharmacokinetics during the first trimester of human pregnancy." Eur J Clin Pharmacol 46 (1994): 451-4
  2. Goldberg M "Analgesic nephropathy in 1981: which drug is responsible?" JAMA 247 (1982): 64-5
  3. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  4. "Product Information. Benylin DM (dextromethorphan)." Warner Lambert Laboratories, Morris Plains, NJ.
  5. Galinsky RE, Levy G "Absorption and metabolism of acetaminophen shortly before parturition." Drug Intell Clin Pharm 18 (1984): 977-9
  6. Rudolph AM "Effects of aspirin and acetaminophen in pregnancy and in the newborn." Arch Intern Med 141 (1981): 358-63
  7. Andaloro VJ, Monaghan DT, Rosenquist TH "Dextromethorphan and other N-methyl-D-aspartate receptor antagonists are teratogenic in the avian embryo model." Pediatr Res 43 (1998): 1-7
  8. Rayburn W, Shukla U, Stetson P, Piehl E "Acetaminophen pharmacokinetics: comparison between pregnant and nonpregnant women." Am J Obstet Gynecol 155 (1986): 1353-6
  9. Debus O, Kurlemann G, Gehrmann J, Krasemann T "Dextromethorphan in pregnancy." Chest 120 (2001): 1038-40
  10. Roberts I, Robinson MJ, Mughal MZ, Ratcliffe JG, Prescott LF "Paracetamol metabolites in the neonate following maternal overdose." Br J Clin Pharmacol 18 (1984): 201-6
  11. Levy G, Garrettson LK, Soda DM "Evidence of placental transfer of acetaminophen." Pediatrics 55 (1975): 895
  12. 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
  13. Einarson A, Lyszkiewicz D, Koren G "The safety of dextromethorphan in pregnancy - Results of a controlled study." Chest 119 (2001): 466-9

References for breastfeeding information

  1. Matheson I, Lunde PK, Notarianni L "Infant rash caused by paracetamol in breast milk." Pediatrics 76 (1985): 651-2
  2. Committee on Drugs, 1992 to 1993 "The transfer of drugs and other chemicals into human milk." Pediatrics 93 (1994): 137-50
  3. 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
  4. "Product Information. Benylin DM (dextromethorphan)." Warner Lambert Laboratories, Morris Plains, NJ.
  5. Findlay JW, DeAngelis RL, Kearney MF, et al "Analgesic drugs in breast milk and plasma." Clin Pharmacol Ther 29 (1981): 625-33
  6. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  7. Findlay JW, Butz RF, Sailstad JM, Warren JT, Welch RM "Pseudoephedrine and triprolidine in plasma and breast milk of nursing mothers." Br J Clin Pharmacol 18 (1984): 901-6
  8. 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

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