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Acetaminophen / pheniramine / phenylephrine Pregnancy and Breastfeeding Warnings

Acetaminophen / pheniramine / phenylephrine is also known as: Scot-Tussin Original, Theraflu Cold & Sore Throat, Theraflu Flu & Sore Throat, Theraflu Sinus & Cold

Acetaminophen / pheniramine / phenylephrine Pregnancy Warnings

Acetaminophen/pheniramine/phenylephrine 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. Pheniramine has not been formally assigned to a pregnancy category by the FDA. 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/pheniramine/phenylephrine is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.

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Acetaminophen / pheniramine / phenylephrine Breastfeeding Warnings

There are no data on the excretion of acetaminophen/pheniramine/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 pheniramine 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.

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References for pregnancy information

  1. Rudolph AM "Effects of aspirin and acetaminophen in pregnancy and in the newborn." Arch Intern Med 141 (1981): 358-63
  2. "Product Information. Lusonal (phenylephrine)." Wraser Pharmaceuticals, Ridgeland, MS.
  3. Galinsky RE, Levy G "Absorption and metabolism of acetaminophen shortly before parturition." Drug Intell Clin Pharm 18 (1984): 977-9
  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. 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. "Product Information. Lusonal (phenylephrine)." Wraser Pharmaceuticals, Ridgeland, MS.
  2. 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
  3. Findlay JW, DeAngelis RL, Kearney MF, et al "Analgesic drugs in breast milk and plasma." Clin Pharmacol Ther 29 (1981): 625-33
  4. Committee on Drugs, 1992 to 1993 "The transfer of drugs and other chemicals into human milk." Pediatrics 93 (1994): 137-50
  5. 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

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