Caution is recommended; benefit to mother should outweigh risk to the infant.

AU TGA pregnancy category: B2
US FDA pregnancy category: Not assigned

Comments:
-Although both active ingredients have been widely used, no specific pregnancy use data is available.

Animal studies are not available for the combination product. There are no controlled data using any of the drugs, alone or in combination, in human pregnancy.

Animals studies of pseudoephedrine at up to 50 times the human daily dose showed no teratogenicity.

Animal studies of triprolidine at up to 75 times the human dose did not show teratogenicity.

AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Caution is recommended; benefit to mother should outweigh risk to the infant.

Excreted into human milk: Yes (pseudoephedrine, triprolidine)

Comments:
-There is no information regarding this drug and the effects on a breastfed infant.
-About 0.5 to 0.7% of an oral pseudoephedrine dose is excreted in breastmilk over 24 hours.

See references