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Acetaminophen / guaifenesin Pregnancy and Breastfeeding Warnings

Acetaminophen / guaifenesin is also known as: Comtrex Deep Chest Cold, Theraflu Flu & Chest Congestion, Tylenol Chest Congestion

Acetaminophen / guaifenesin Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned

Comments:
-Acetaminophen is commonly used during pregnancy and has been assumed safe; recent data questions the safety, especially with routine use or varying genetics.
-Routine use of acetaminophen during pregnancy is not advised.
-Available data do not indicate developmental toxicity with guaifenesin.

Animal studies are not available for the combination product. There are no controlled data in human pregnancy.

Acetaminophen: Routinely used during all stages of pregnancy, it appears safe for short-term use. This drug crosses the placenta.

Guaifenesin: Animal studies are not available. A monitoring study including 197 mother-child pairs that had first trimester guaifenesin exposure showed an increase in inguinal hernias; 1336 any time pregnancy exposures showed no association with malformations.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Acetaminophen / guaifenesin Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Yes (acetaminophen) /Data not available (guaifenesin)
Excreted into animal milk: Data not available (guaifenesin)

Comments:
-The amount of acetaminophen in breast milk is much less than typical infant doses.
-One study calculated that infants receive about 0.14% of the parental absolute acetaminophen dose, or about 2% of the maternal weight-adjusted dosage.
-Guaifenesin from breast milk is not expected to adversely affect nursing infants at normal parental doses.

See references

References for pregnancy information

  1. Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation. 10th ed." Philadelphia, PA: Wolters Kluwer Health (2015):
  2. The Buckley's Company "Buckley's Complete + Mucus. Available from: URL: https://www.buckleys.ca/products/syrups/complete-mucus-syrup/" ([2019]):

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  2. The Buckley's Company "Buckley's Complete + Mucus. Available from: URL: https://www.buckleys.ca/products/syrups/complete-mucus-syrup/" ([2019]):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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