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Acetaminophen / dextromethorphan / phenylephrine Pregnancy and Breastfeeding Warnings

Acetaminophen / dextromethorphan / phenylephrine is also known as: Alka-Seltzer Plus Day & Night Cold Formula (Day Cold) Liquid Gels, Alka-Seltzer Plus Day Non-Drowsy Cold & Flu Formula Liquid Gels, Alka-Seltzer Plus Day Non-Drowsy Cold Formula Liquid Gels, Alka-Seltzer Plus Multi-Symptom Cold & Flu (Day Formula), Alka-Seltzer Plus Severe Sinus Congestion & Cough (Day Formula), Alka-Seltzer Plus Severe Sinus Congestion & Cough Liquid Gels, 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, Sudafed PE Pressure+Pain+Cough, Theraflu Daytime Severe Cold & Cough, Theraflu Multi-Symptom Severe Cold, 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

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.

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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. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  2. "Product Information. Benylin DM (dextromethorphan)." Warner Lambert Laboratories, Morris Plains, NJ.
  3. 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
  4. Rudolph AM "Effects of aspirin and acetaminophen in pregnancy and in the newborn." Arch Intern Med 141 (1981): 358-63
  5. Rayburn W, Shukla U, Stetson P, Piehl E "Acetaminophen pharmacokinetics: comparison between pregnant and nonpregnant women." Am J Obstet Gynecol 155 (1986): 1353-6
  6. "Product Information. Lusonal (phenylephrine)." Wraser Pharmaceuticals, Ridgeland, MS.
  7. Levy G, Garrettson LK, Soda DM "Evidence of placental transfer of acetaminophen." Pediatrics 55 (1975): 895
  8. Galinsky RE, Levy G "Absorption and metabolism of acetaminophen shortly before parturition." Drug Intell Clin Pharm 18 (1984): 977-9
  9. 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
  10. Einarson A, Lyszkiewicz D, Koren G "The safety of dextromethorphan in pregnancy - Results of a controlled study." Chest 119 (2001): 466-9
  11. Beaulac-Baillargeon L, Rocheleau S "Paracetamol pharmacokinetics during the first trimester of human pregnancy." Eur J Clin Pharmacol 46 (1994): 451-4
  12. Byer AJ, Traylor TR, Semmer JR "Acetaminophen overdose in the third trimester of pregnancy." JAMA 247 (1982): 3114-5
  13. Debus O, Kurlemann G, Gehrmann J, Krasemann T "Dextromethorphan in pregnancy." Chest 120 (2001): 1038-40
  14. 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

References for breastfeeding information

  1. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  2. "Product Information. Benylin DM (dextromethorphan)." Warner Lambert Laboratories, Morris Plains, NJ.
  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. Matheson I, Lunde PK, Notarianni L "Infant rash caused by paracetamol in breast milk." Pediatrics 76 (1985): 651-2
  5. Committee on Drugs, 1992 to 1993 "The transfer of drugs and other chemicals into human milk." Pediatrics 93 (1994): 137-50
  6. "Product Information. Lusonal (phenylephrine)." Wraser Pharmaceuticals, Ridgeland, MS.
  7. Findlay JW, DeAngelis RL, Kearney MF, et al "Analgesic drugs in breast milk and plasma." Clin Pharmacol Ther 29 (1981): 625-33
  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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