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 4, 2024.
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.
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 also
References for pregnancy information
- Cerner Multum, Inc. "UK Summary of Product Characteristics."
- (2022) "Product Information. Pepcid Complete (calcium carbonate/famotidine/Mg hydroxide)." Johnson and Johnson/McNeil Consumer
References for breastfeeding information
- Cerner Multum, Inc. "UK Summary of Product Characteristics."
- United States National Library of Medicine (2013) Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
- 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
- Briggs GG, Freeman RK. (2015) "Drugs in Pregnancy and Lactation." Philadelphia, PA: Wolters Kluwer Health
- (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.