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Generic Name
Paracetamol (Acetaminophen), Codeine phosphate and Caffeine
Trade Name
Sterling Health
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 is B for paracetamol and caffiene.
FDA Pregnancy Risk Categories

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  • analgesic, antitussive.
  • Antipyretic.
  • Fetal Risk
    Fetal Risk
  • No well - controlled data for codeine but suggested possible association with respiratory, genitourinary malformations, Downs syndrome, umbilical and inguinal hernias, pyloric sterosis and hydro-cephaly, and for opiates in general suggested to produce cleft lip / palate, heart, musculoskeletal, gastrointestinal malformations and inguinal hernias.
  • High doses of Codeine at term, can cause neonatal withdrawal and respiratory depression.
  • No adequate 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 used any time during pregnancy.
  • Low doses of aspirin (acetylsalicylic acid) of less than 150mg have no fetal risk but high doses in the 3rd trimester can cause premature closure of pulmonary artery to aorta">ductus arteriosus with subsequent neonatal pulmonary hypertension, intrauterine growth retardation, stillbirth, congenital salicylate intoxication (agitation, hypertonia), and bleeding disorders in the newborn.
  • Controversial association with congenital anomalies (oral clefts, heart defects) and Low IQ of children exposed to the drug in utero in the 1st half of pregnancy.
  • Breast Feeding
    Breast Feeding
  • All the drugs are excreted into milk.
  • Codeine and paracetamol are safe although reported single case of maculo-papular rashin infant exposed to paracetamol.
  • Aspirin should be used with caution because of potential adverse effects on infants platelet function.
  • 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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