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Guaifenesin / hydrocodone Pregnancy and Breastfeeding Warnings

Brand names: Atuss HX, Co-Tuss V Expectorant, Co-Tussin, CodiCLEAR DH, Codotuss, Condasin, EndaCof-Tab, Endacof XP, Execlear, Fentuss Expectorant, Flowtuss, Hycotuss Expectorant, Kwelcof, Maxi-Tuss HCG, Monte-G HC, Narcof, Obredon, Pneumotussin HC, Propatuss Expectorant, Tusso-HC, Vi-Q-Tuss, Vicoclear, Vicodin Tuss, Vortex, Ztuss ZT

Guaifenesin / hydrocodone Pregnancy Warnings

Use is not recommended unless the benefit outweighs the risk to the fetus

US FDA pregnancy category: C

Comments: Prolonged use of opioids during pregnancy can result in physical dependence in the neonate; women should be advised of the risk of neonatal abstinence syndrome and ensure that appropriate treatment will be available.

Animal studies have not been conducted with this combination product, but there are studies with hydrocodone showing teratogenicity in hamsters with doses approximately 27 times the maximum recommended human daily dose. Babies born to mothers taking opioids regularly during pregnancy may become physically dependent. Opioids given to the mother shortly before delivery may produce some degree of respiratory depression in the newborn, especially if high doses are used. There are no controlled data in human pregnancy.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Guaifenesin / hydrocodone Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, considering the importance of the drug to the mother

Excreted into human milk: Yes (hydrocodone); Unknown (guaifenesin)

Comments: Breastfed infants should be closely monitored for increased sedation, difficulty breastfeeding, breathing difficulties, or limpness; mothers should be counseled to seek immediate medical assistance if these develop.

See references

References for pregnancy information

  1. Product Information. Flowtuss (guaifenesin-hydrocodone). Mission Pharmacal Company. 2017.

References for breastfeeding information

  1. United States National Library of Medicine. Toxnet. Toxicology Data Network. 2013.
  2. Product Information. Flowtuss (guaifenesin-hydrocodone). Mission Pharmacal Company. 2017.

Further information

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