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Acetaminophen / aspirin / caffeine Pregnancy and Breastfeeding Warnings

Medically reviewed by Last updated on Jul 19, 2022.

Acetaminophen / aspirin / caffeine is also known as: Anacin Advanced Headache Formula, Arthriten, Arthriten Inflammatory Pain Formula, Backaid Inflammatory Pain Formula, Bayer Migraine Formula, CVS Extra Strength Headache Relief, ConRx Pain Reliever, Excedrin, Excedrin Extra Strength, Excedrin Menstrual Complete, Excedrin Migraine, Extra Pain Relief, Genace, Goody's Extra Strength, Goody's Extra-Strength Headache Powders, Goody's Headache Powders, Medique Pain-Off, Migraine Formula, Migraine Relief, PainAid Extra-Strength Formula, Pamprin Max Menstrual Pain Relief, Supac, Uricalm Intensive, Vanquish

Acetaminophen / aspirin / caffeine Pregnancy Warnings

Aspirin inhibits prostaglandin synthesis. When given late in pregnancy, it may cause premature closure of the fetal ductus arteriosus, delay labor and birth. Aspirin increases the bleeding time both in the newborn infant and in the mother because of its antiplatelet effects. Low-dose aspirin (100 mg/day) does not affect bleeding time. High-dose aspirin (2 g per day) has been associated with stillbirths, cerebral hemorrhage, oculoauriculovertebral dysplasia, neonatal salicylate toxicity, constricted ductus arteriosus, cyclopia, and neonatal acidosis. Some cases of congenital heart defects have been reported. The American College of Obstetricians and Gynecologists and the US Preventative Services Task Force support the use of low-dose aspirin prophylaxis in women at high-risk of preeclampsia

Caffeine crosses the placenta. Fetal blood and tissue levels in the fetus are similar to those in the mother. Caffeine has been reported to be an animal teratogen with doses high enough to cause toxicity in the mother. In 1980, the Food and Drug Administration issued an advisory (based primarily on animal evidence) which stated that pregnant women should limit intake of caffeine to a minimum. The American College of Obstetricians and Gynecologists concludes that a definitive relationship of high caffeine intake and miscarriage cannot be determined, moderate caffeine consumption (less than 200 mg total per day) does not appear to be a contributing factor in miscarriage or preterm birth. There are no controlled data in combined use of this drug in human pregnancy.

US FDA pregnancy category: Not formally assigned to a pregnancy category due to product being available over-the-counter. Over-the-counter warning: It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Avoid use during the first two trimesters of pregnancy unless the benefit outweighs the risk to the fetus; not recommended during the third trimester of pregnancy

US FDA pregnancy category: Not formally assigned to a pregnancy category

-Acetaminophen (paracetamol): Intermittent doses have not been associated with harm.
-Aspirin: Chronic or intermittent high doses should be avoided, especially during the third trimester of pregnancy.
-Caffeine: Conflicting data exits as to whether there is a correlation with high caffeine intake and miscarriage; moderate consumption (less than 200 mg/day) does not appear to contribute to miscarriage or preterm birth.

See references

Acetaminophen / aspirin / caffeine Breastfeeding Warnings

Acetaminophen (paracetamol) is generally considered a good choice for analgesia and fever reduction while breastfeeding as the amounts in milk are much less than doses usually given to infants.

Aspirin is rapidly metabolized to salicylate after ingestion; salicylic acid is excreted into human milk. Metabolic acidosis has been reported in one breastfed infant following long-term, high-dose maternal aspirin ingestion. Regular/high doses of maternal aspirin could impair platelet function in the breastfed infant. Reye's syndrome is associated with aspirin use in infants with viral infections, but the risk from salicylate in breastmilk is unknown. Daily low-dose aspirin (75 to 325 mg per day) has yielded low salicylate levels in breastmilk and some experts suggest low dose aspirin may be considered for antiplatelet therapy in breastfeeding women.

Caffeine is excreted into human milk; there is insufficient data to quantify a safe maternal caffeine dose while breastfeeding. Fussiness, jitteriness and poor sleep patterns have been reported in infants of mothers with very high caffeine intake (about 10 or more cups of coffee daily) while studies in mothers taking half that (5 cups of coffee daily) found no stimulation in breastfed infants 3 weeks or older. Preterm and younger newborns metabolize caffeine slowly so a lower intake in mothers of these infants is preferable. A coffee intake of more than 450 mL per day may decrease breastmilk iron concentrations and result in mild iron deficiency anemia in some breastfed infants.

Benefit should outweigh risk

Excreted into human milk: Yes

-Because this combination product contains aspirin and caffeine, an alternative therapy should be considered, especially when nursing younger infants.

See references

References for pregnancy information

  1. Karlowicz MG, White LE "Severe intracranial hemorrhage in a term neonate associated with maternal acetylsalicylic acid ingestion." Clin Pediatr (Phila) 32 (1993): 740-3
  2. "Clasp: a randomised trial lf low-dose aspirin for the prevention and treatment of pre-eclampsia among 9364 pregnant women." Lancet 343 (1994): 619-29
  3. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation." Baltimore, MD: Williams & Wilkins (1998):
  4. "Product Information. Bayer Aspirin (acetylsalicylsyra)." Bayer
  5. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  6. "Product Information. Pamprin Max (acetaminophen/aspirin/caffeine)." Chattem Consumer Products (2022):

References for breastfeeding information

  1. "Product Information. Bayer Aspirin (acetylsalicylsyra)." Bayer
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. United States National Library of Medicine "Toxnet. Toxicology Data Network." (2013):
  4. "Product Information. Pamprin Max (acetaminophen/aspirin/caffeine)." Chattem Consumer Products (2022):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.