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Generic Name
Dextromethorphan hydrobromide, Guaiphenesin (guaifenesin), Ephedrine and Chlorpheniramine maleate
Trade Name
Broncholar
Risk Category
C*
  • Studies on animals show adverse effect and toxicity on fetus.
  • No adequate and well controlled studies done on pregnant women.
  • Drugs should be given only if the potential benefit outweighs the potential risk to the fetus.
The risk category is B for chlorpheniramine maleate.
FDA Pregnancy Risk Categories

Place (not click) your mouse cursor over the bold words in the text below to receive description

Indication
Indication
  • antitussive.
  • Expectorant.
  • Fetal Risk
    Fetal Risk
  • Ephedrine is teratogenic in animals, no adequate human data but for sympathomimetic drugs in general has been reported association with minor congenital anomalies, inguinal hernia and club foot if used in 1st trimester.
  • It also increases fetal heart rate.
  • No adequate human data for guaifenesin (guaiphenesin), but suggested possible association with inguinal hernia if used in 1st trimester, no fetal adverse effect has been reported when used in the last two trimesters.
  • No well - controlled human data for chlorpheniramine, suggested possible association with congenital malformations including polydactyly, eye, ear defects, inguinal hernia, gastrointestinal and genital defects, dislocation of the hip.
  • Use of antihistamines in the last two weeks of pregnancy reported to cause retrolental fibroplasia in premature infants.
  • Limited data for dextromethorphan but considered to be safe in pregnancy.
  • No animal data.
  • Breast Feeding
    Breast Feeding
  • No data available for dextromethorphan, chlorpheniramine and guaifenesin (guaiphenesin) in breast feeding ephedrine is cosidered safe, but reported single case of irritability and poor sleeping in nursing infant.
  • Other Trade Names
     
    The information on this Web site is not intended as a substitute for the advice and care of your doctor or other health-care provider. Always consult your doctor if you have any questions about exposures during pregnancy and lactation, and before you take any medications. Please read the Terms and Conditions before using this website.
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