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Generic Name
Paracetamol (acetaminophen) and Phenylpropanolamine hydrochloride
Trade Name
Sinutab
Manufacturer
Parke – Davis
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 paracetamol.
FDA Pregnancy Risk Categories

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Indication
Indication
  • decongestant.
  • Analgesic.
  • Fetal Risk
    Fetal Risk
  • No adequate human data for phenylpropanolamine, suggested association with eye, ear defects, hypospadias, cataract, polydactyly, pectus excavatum in 1st trimester exposure and with dislocation of the hip if used any time in pregnancy.
  • It may cause spasm of uterine vesseles leading to fetal hypoxia.
  • No adequate human data for paracetamol but reported that toxic maternal doses can cause fetal liver toxicity, kidney abonormalities and intrauterine death.
  • Suggested possible association with congenital dislocation of the hip and club foot if used any time in pregnancy.
  • Breast Feeding
    Breast Feeding
  • Paracetamol is excreted into milk in small amounts. Safe in breast feeding, reported single case of maculopapular rash in exposed infant.
  • No data for phenylpropanolamine.
  • 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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