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Generic Name
Glyceryl guaiacolate (guaiphenesin), chlorpheniramine maleate, phenylephrine hydrochloride
Trade Name
Soolan
Manufacturer
Julphar
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

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Indication
Indication
  • Cough preparation.
  • Fetal Risk
    Fetal Risk
  • No adequate human data for guaiphenesin but suggested possible association with inguinal hernia if used in 1st trimester, no fetal adverse effects have been reported when used in the last two trimesters.
  • No well – controlled human data for chlorpheniramine. Reported 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.
  • Phenylephrine is teratogenic in animals, no well-controlled human data but suggested possible association with eye, ear, digital defects and clubfoot during 1st trimester exposure and with musculoskeletal defects and umbilical hernia during exposure any time in pregnancy. It may cause uterine vessel spasm resulting in fetal bradycardia and hypoxia.
  • Breast Feeding
    Breast Feeding
  • No data available for all agents in breast feeding.
  • 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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