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Aluminum hydroxide / magnesium hydroxide / simethicone Pregnancy and Breastfeeding Warnings

Brand names: Almacone, Almacone-2, Di-Gel, Flanax Antacid Liquid, Gelusil, Maalox, Maalox Advanced Maximum Strength, Maalox Advanced Regular Strength, Mag-al Plus, Magaant, Masanti, Masanti DS, Mi-Acid, Milantex, Milantex Maximum Strength, Mintox, Mintox Maximum Strength, Mintox Plus, Mylanta, Mylanta DS Fast Acting, Mylanta Fast Acting, Mylanta Maximum Strength, Rulox, Tempo, Urban

Medically reviewed by Drugs.com. Last updated on Aug 3, 2023.

Aluminum hydroxide / magnesium hydroxide / simethicone Pregnancy Warnings

Caution is recommended.

AU TGA pregnancy category: Not formally assigned to a pregnancy category. This class of drugs is generally exempt from pregnancy classification.
US FDA pregnancy category: Not formally assigned to a pregnancy category.

Comment: Simethicone is not orally absorbed.

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

See references

Aluminum hydroxide / magnesium hydroxide / simethicone Breastfeeding Warnings

Caution is recommended.

Excreted into human milk: Yes (Aluminum hydroxide, magnesium hydroxide); No (simethicone)

Comments:
-The WHO considers aluminum hydroxide and magnesium hydroxide compatible with breastfeeding.
-Simethicone is not orally absorbed and has been used safely in infants.

See references

See also

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. Cerner Multum, Inc. "Australian Product Information."
  3. (2022) "Product Information. Antacid Regular Strength (Al hydroxide/Mg hydroxide/simethicone)." Geri-Care Pharmaceuticals
  4. (2022) "Product Information. Mylanta Maximum Strength Vanilla Caramel (Al hydroxide/Mg hydroxide/simethicone)." Infirst Healthcare Inc

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. Cerner Multum, Inc. "Australian Product Information."
  3. United States National Library of Medicine (2013) Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
  4. 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
  5. (2022) "Product Information. Antacid Regular Strength (Al hydroxide/Mg hydroxide/simethicone)." Geri-Care Pharmaceuticals
  6. (2022) "Product Information. Mylanta Maximum Strength Vanilla Caramel (Al hydroxide/Mg hydroxide/simethicone)." Infirst Healthcare Inc

Further information

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

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