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Generic Name
Paracetamol (Acetaminophen), pseudoephedrine HCl and chlorpheniramine maleate
Trade Name
Adol Allergy Maleate
Risk Category
  • 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 for paracetamol, chlorpheniramine is B.
FDA Pregnancy Risk Categories

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  • Analgesic.
  • Antipyretic.
  • Antihistamine.
  • Fetal Risk
    Fetal Risk
  • No adequate human data for paracetamol but reported that maternal toxic doses can cause fetal liver toxicity, kidney abnormalities and intrauterine death. Suggested possible association with congenital dislocation of the hip and club foot if paracetamol used anytime during pregnancy.
  • 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 and possibly associated with minor malformations, club foot and inguinal hernias in human pregnancy.
  • No well-controlled human data for chlorpheniramine, suggested possible association with congenital malformations including: polydactyly, eye, ear, defects, dislocation of the hip.
  • Use of antihistamine in the last two weeks of pregnancy reported to cause retrolental fibroplasia in premature infants.
  • Breast Feeding
    Breast Feeding
  • Paracetamol is excreted into milk in small amounts, safe in breast feeding but reported single case of maculopapular rash in nursing infant.
  • Pseudoephedrine is excreted into milk, safe in breast feeding.
  • No data available for chlorpheniramine 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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