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Generic Name
Aspirin (Acetylsalicylic acid) 500 mg and Codeine Phosphate
Trade Name
Reckitt Colman
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.
For Aspirin the category is C if used in low doses (< 150 mg/day).
The risk category for Aspirin will be D if used in full doses in 3rd trimester.
FDA Pregnancy Risk Categories

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  • Analgesic.
  • Antipyretic.
  • Anti-inflammatory.
  • Fetal Risk
    Fetal Risk
  • Low doses of Aspirin have no fetal risk, but high doses in the 3rd trimester can cause premature closure of pulmonary artery to aorta">ductus arteriosus, neonatal pulmonary hypertension, still birth and intrauterine growth retardation.
  • High doses near term can cause bleeding disorders in the neonates.
  • Controversial association with congenital malformations (heart defects and oral cleft palate is a split in roof of the mouth, due to failure of two sides to fuse during embryonic development. Could also be a cleft lip, which is a split in the lip">clefts) if used in 1st trimester.
  • Questionable effects of high doses of aspirin on the IQ of children exposed in utero in the first half of pregnancy.
  • High doses can cause congenital salicylate intoxication (hypertonia, irritability).
  • No well-controlled data for codiene, but suggested possible association with respiratory and genito-urinary malformations, down syndrome, umbilical and inguinal hernias, pyloric stenosis and hydrocephaly.
  • Opiates in general are suggested to produce cleft lip/palate, heart, musculoskeletal, gastrointestinal malformations and inguinal hernias.
  • High doses of codiene at term can cause neonatal withdrawal and respiratory depression.
  • Breast Feeding
    Breast Feeding
  • Aspirin is excreted into milk in small amounts, should be used with caution because of possible adverse effects on infant platelet function.
  • Codeine is safe 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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