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Generic Name
Triprolidine hydrochloride, Pseudoephedrine hydrochloride, Dextromethorphan hydrobromide and Guaifenesin
Trade Name
Unifed extra
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.
FDA Pregnancy Risk Categories

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Indication
Indication
  • expectorant.
  • Decongestant.
  • Fetal Risk
    Fetal Risk
  • No fetal adverse effects for triprolidine in animals but no well – controlled human data, suggested possible association with cardiovascular defects in 1st trimester exposure.
  • No adequate data for pseudoephedrine but suggested possible association with gastroschisis in 1st trimester exposure and for sympathomimetic drugs in general, they are teratogenic in animals possibly associated with minor malformations, club foot and inguinal hernias in human pregnancy.
  • No animal data for Dextromethorphan, limited human data but reported to be safe in pregnancy.
  • No adequate data for guaifenesin but suggested possible association with inguinal hernia in 1st trimester.
  • No fetal adverse effects have been reported when the drug used in the last two trimesters
  • Breast Feeding
    Breast Feeding
  • Triprolidine and pseudoephedrine are excreted into milk safe in breast feeding.
  • No data available for Dextromethorphan.
  • No data available for guaifenesin.
  • 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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