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Acetaminophen / caffeine / phenyltoloxamine Pregnancy and Breastfeeding Warnings

Acetaminophen / caffeine / phenyltoloxamine is also known as: Flextra, Flextra Plus

Acetaminophen / caffeine / phenyltoloxamine Pregnancy Warnings

Acetaminophen/caffeine/phenyltoloxamine 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/caffeine/phenyltoloxamine is only recommended for use during pregnancy when benefit outweighs risk.

Acetaminophen / caffeine / phenyltoloxamine 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. Caffeine is excreted into human milk in small amounts. Adverse effects in the nursing infant are unlikely. However, irritability and poor sleep patterns have been reported in nursing infants. The amount of caffeine generally found in caffeinated beverages is considered to usually be compatible with breast-feeding by the American Academy of Pediatrics. Because caffeine is excreted into human milk and because caffeine is metabolized slowly by nursing infants, consumption of more than moderate levels of caffeine by nursing mothers is not recommended. There are no data on the excretion of phenyltoloxamine into human 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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