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Guaifenesin / hydrocodone / pseudoephedrine Pregnancy and Breastfeeding Warnings

Guaifenesin / hydrocodone / pseudoephedrine is also known as: Deconamine CX, Decotuss-HD, Detussin Expectorant, Drituss HD, Dynex HD, Entex HC, Entuss-D, Entuss-D JR, Hydro-Tuss XP, Hydrotussin HD, Hytussin Expectorant, KG-Tuss HD, Medtuss HD, Nalex Expectorant, Poly-Tussin XP, Pseudatex HC, SRC Expectorant, Spantuss HD, Su-Tuss HD Elixir, Tussadur-HD, Tussafin Liquid, Tussend Expectorant, Tussgen Expectorant, Vanacon, Vanex Expectorant

Medically reviewed on August 25, 2017

Guaifenesin / hydrocodone / pseudoephedrine 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 studies have shown teratogenicity in hamsters with hydrocodone doses approximately 35 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 / pseudoephedrine 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, pseudoephedrine); 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. Hycofenix (guaifenesin/hydrocodone/pseudoephedrine)." Mission Pharmacal Company, San Antonio, TX.

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. "Product Information. Hycofenix (guaifenesin/hydrocodone/pseudoephedrine)." Mission Pharmacal Company, San Antonio, TX.

Further information

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

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