Dextromethorphan / guaifenesin / pseudoephedrine Pregnancy and Breastfeeding Warnings

Dextromethorphan / guaifenesin / pseudoephedrine is also known as: Ambi 600/1000/30, Ambi 80/780/40, Balminil DM + Decongestant + Expectorant, Benylin DM-D-E, Capmist DM, Despec DM, Dimacol, Donatussin DM Syrup, Dorcol Childrens Cough, Entex Pac, Entre-Cough, Mardrops-DX, Maxifed DM, Medent DM, Medent-DMI, Novahistine DMX, PanMist DM, Poly-Vent DM, SudaTex-DM, Sudafed Cough, Sudafed Cough Syrup, TL-Dex DM, Tusnel, Tusnel Pediatric, 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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