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Calcium carbonate / famotidine / magnesium hydroxide Pregnancy and Breastfeeding Warnings

Calcium carbonate / famotidine / magnesium hydroxide is also known as: 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, Pepcid Complete, Tums Dual Action

Medically reviewed by Drugs.com. Last updated on Dec 17, 2018.

Calcium carbonate / famotidine / magnesium hydroxide Pregnancy Warnings

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

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.

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. "Product Information. Pepcid Complete (calcium carbonate/famotidine/Mg hydroxide)." Johnson and Johnson/McNeil Consumer, Fort Washington, PA.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  3. Department of Adolescent and Child Health and Development. UNICEF. World Health Organization "Breastfeeding and maternal medication: recommendations for drugs in the eleventh Who model list of essential drugs. Available from: URL: http://whqlibdoc.who.int/hq/2002/55732.pdf?ua=1" ([2003]):
  4. "Product Information. Pepcid Complete (calcium carbonate/famotidine/Mg hydroxide)." Johnson and Johnson/McNeil Consumer, Fort Washington, PA.
  5. Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation. 10th ed." Philadelphia, PA: Wolters Kluwer Health (2015):

Further information

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

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