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Dextromethorphan / guaifenesin / pseudoephedrine Pregnancy and Breastfeeding Warnings

Dextromethorphan / guaifenesin / pseudoephedrine is also known as: Ambenyl-D, Ambi 60/580/30, Ambi 600/1000/30, Ambi 80/780/40, Ambifed DM, Balminil DM + Decongestant + Expectorant, Benylin DM-D-E, Calmylin 4, Capmist DM, Despec Drops, Dimacol, Entex Pac, Entre-Cough, Mardrops-DX, Maxifed DM, Medent-DMI, PanMist DM, Poly-Vent DM, Relasin DM, Sudafed Cough, Sudafed Cough Syrup, TL-Dex DM, Tusnel, Tusnel-DM Pediatric Drops, Z-Cof 8DM

Dextromethorphan / guaifenesin / pseudoephedrine Pregnancy Warnings

Dextromethorphan animal studies have revealed evidence of teratogenicity. Based on available data, pseudoephedrine is not thought to be teratogenic. There are no controlled data in human pregnancy. 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.

FDA pregnancy category: C (dextromethorphan and guaifenesin). Pseudoephedrine has not been formally assigned to a pregnancy category by the FDA. Only recommended for use during pregnancy when benefit outweighs risk.

Dextromethorphan / guaifenesin / pseudoephedrine Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation. Excreted into human milk: Yes (pseudoephedrine); Unknown (dextromethorphan and guaifenesin) Excreted into animal milk: Unknown The effects in the nursing infant are unknown.

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