Dextromethorphan / pseudoephedrine / triprolidine Pregnancy and Breastfeeding Warnings
Brand names: Pediatex TDM
Medically reviewed by Drugs.com. Last updated on Apr 30, 2025.
Dextromethorphan / pseudoephedrine / triprolidine Pregnancy Warnings
According to some authorities: This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.
US FDA pregnancy category: Not formally assigned to a pregnancy category.
Animal studies have failed to reveal evidence of teratogenicity. Systemic administration of pseudoephedrine, up to 50 times the human daily dosage in rats and up to 35 times the human daily dosage in rabbits, did not produce teratogenic effects. In rats and rabbits, systemic administration of triprolidine up to 75 times the human daily dosage did not produce teratogenic effects. There are no controlled data in human pregnancy.
Dextromethorphan / pseudoephedrine / triprolidine Breastfeeding Warnings
Use is considered acceptable; caution is recommended.
Excreted into human milk: Yes (dextromethorphan, pseudoephedrine, triprolidine)
The concentrations of dextromethorphan and its active metabolite present in breast milk are negligible, and it is unlikely to exert any adverse effects on the nursing infant.
Pseudoephedrine in breast milk is unlikely to harm the nursing infant but may cause occasional irritability. A single dose can reduce milk production temporarily, while repeated use may affect lactation. It's generally advised that mothers with newborns who are still establishing a milk supply, or those struggling with low milk production, avoid taking pseudoephedrine.
Small, occasional amounts of triprolidine are generally not expected to harm breastfed babies. But taking higher doses or using it for a longer time may affect the infant or lower milk supply, especially when used with a sympathomimetic like pseudoephedrine or before breastfeeding is fully established.
See also
References for pregnancy information
- (2025) "Product Information. Histex-DM New Formulation (Pseudoephedrine) (dextromethorphan/pseudoephedrine/triprolidine)." Allegis Pharmaceuticals
References for breastfeeding information
- (2025) "Product Information. Histex-DM New Formulation (Pseudoephedrine) (dextromethorphan/pseudoephedrine/triprolidine)." Allegis Pharmaceuticals
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.