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Generic Name
Dextromethorphan, Pseudoephedrine and Chlorpheniramine maleate
Trade Name
Benical
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.
FDA Pregnancy Risk Categories

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Indication
Indication
  • Antitussive.
  • Decongestant.
  • Fetal Risk
    Fetal Risk
  • No animal data for dextromethorphan, limited human data but reported to be safe in pregnancy.
  • No adequate data for pseudoephedrine, suggested possible association with gastroschisis in 1st trimester exposure, and for sympathomimetic drugs in general, they are teratogenic in animals and possibly associated with minor malformations, club foot and inguinal hernias in human pregnancy.
  • No well – controlled human data for chlorpheniramine, suggested possible associations 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.
  • Breast Feeding
    Breast Feeding
  • No data for chlorpheniramine and dextromethorphan in breast feeding.
  • Pseudoephedrine is excreted into milk and is safe.
  • 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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