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Calcium carbonate / famotidine / magnesium hydroxide Pregnancy and Breastfeeding Warnings

Brand names: Acid Controller Complete, Acid Controller Complete Dual Action, Acid Reducer Plus Antacid, Complete Acid Reducer plus Antacid, Dual Action Complete, Dual-Action Acid Controller Complete, Duo Fusion, Pepcid Complete, Tums Dual Action

Medically reviewed by Drugs.com. Last updated on Nov 6, 2023.

Calcium carbonate / famotidine / magnesium hydroxide Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

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

Animal studies have not been reported. There are no controlled data using either of the drugs, alone or in combination, in human pregnancy.

See references

Calcium carbonate / famotidine / magnesium hydroxide Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes

Comments:
-The effects of the combination product in the nursing infant are unknown.
-The WHO considers magnesium hydroxide compatible with breastfeeding.
-The American Academy of Pediatrics classified a similar agent (cimetidine) as compatible with breastfeeding.
-Some authorities recommend monitoring breastfed infants for adverse effects (e.g., diarrhea).

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. (2022) "Product Information. Pepcid Complete (calcium carbonate/famotidine/Mg hydroxide)." Johnson and Johnson/McNeil Consumer

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. United States National Library of Medicine (2013) Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
  3. Department of Adolescent and Child Health and Development. UNICEF. World Health Organization (2014) Breastfeeding and maternal medication: recommendations for drugs in the eleventh Who model list of essential drugs. http://whqlibdoc.who.int/hq/2002/55732.pdf?ua=1
  4. Briggs GG, Freeman RK. (2015) "Drugs in Pregnancy and Lactation." Philadelphia, PA: Wolters Kluwer Health
  5. (2022) "Product Information. Pepcid Complete (calcium carbonate/famotidine/Mg hydroxide)." Johnson and Johnson/McNeil Consumer

Further information

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