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Dextromethorphan / guaifenesin / pseudoephedrine Pregnancy and Breastfeeding Warnings

Dextromethorphan / guaifenesin / pseudoephedrine is also known as: 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 DM, Dimacol, Entex Pac, Entre-Cough, Mardrops-DX, Maxifed DM, Medent-DMI, Novahistine DM Expectorant with Decongestant, PanMist DM, Poly-Vent DM, Robitussin Cough & Cold D, Sudafed Cough, Sudafed Cough Syrup, TL-Dex DM, Tenar DM, Tusnel, Z-Cof 8DM

Medically reviewed on December 14, 2016

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.

See references

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.

See references

References for pregnancy information

  1. "Product Information. Capmist DM (dextromethorphan/guaiFENesin/pseudoephedrine)." Capital Pharmaceutical, Powell, OH.
  2. "Product Information. Tusnel (dextromethorphan/guaiFENesin/pseudoephedrine)." Llorens Pharmaceuticals, Miami, FL.
  3. "Product Information. Z-Cof 12DM (dextromethorphan/guaifenesin/pseudoephedrine)." Zyber Pharmaceuticals Inc, Gonzales, LA.
  4. "Product Information. Tusnel Pediatric Drops (guaiFENesin-pseudoephedrine)." Llorens Pharmaceuticals, Miami, FL.
  5. "Product Information. ExeFen-DMX (dextromethorphan/guaiFENesin/pseudoephedrine)." Larken Laboratories Inc, Madison, MS.

References for breastfeeding information

  1. "Product Information. Tusnel Pediatric Drops (guaiFENesin-pseudoephedrine)." Llorens Pharmaceuticals, Miami, FL.
  2. "Product Information. Z-Cof 12DM (dextromethorphan/guaifenesin/pseudoephedrine)." Zyber Pharmaceuticals Inc, Gonzales, LA.
  3. "Product Information. ExeFen-DMX (dextromethorphan/guaiFENesin/pseudoephedrine)." Larken Laboratories Inc, Madison, MS.
  4. "Product Information. Capmist DM (dextromethorphan/guaiFENesin/pseudoephedrine)." Capital Pharmaceutical, Powell, OH.
  5. "Product Information. Tusnel (dextromethorphan/guaiFENesin/pseudoephedrine)." Llorens Pharmaceuticals, Miami, FL.

Further information

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

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