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Simethicone Pregnancy and Breastfeeding Warnings

Brand names: Alka-Seltzer Anti-Gas, Anti-Gas Ultra Strength, Baby Gasz, Bicarsim, Bicarsim Forte, CVS Gas Relief, Colic Drops, Colicon, Gas Relief Extra Strength, Gas-X, Gas-X Extra Strength, Gas-X Regular Strength, Gas-X Ultra Strength, Maalox Anti-Gas, Major-Con, Maximum Strength Phazyme 125 Softgels, Mylanta Gas, Mylanta Gas Maximum Strength, Mylicon, Ovol, PediaCare Infants' Gas Relief Drops, Phazyme, Phazyme Maximum Strength, Phazyme-95, SimePed

Medically reviewed by Drugs.com. Last updated on Apr 9, 2024.

Simethicone Pregnancy Warnings

Benefit should outweigh risk.

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: This drug is not orally absorbed.

Animal studies have not been reported. There are no controlled data in human pregnancy.

See references

Simethicone Breastfeeding Warnings

Caution is recommended.

Excreted into human milk: No

Comments:
-This drug is not orally absorbed.
-This drug has been used safely in infants.

See references

References for pregnancy information

  1. (2001) "Product Information. Mylicon (simethicone)." Johnson and Johnson Medical Inc
  2. (2003) "Product Information. Maalox Anti-Gas Extra Strength (simethicone)." Novartis Consumer Health
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  4. Cerner Multum, Inc. "Australian Product Information."

References for breastfeeding information

  1. (2001) "Product Information. Mylicon (simethicone)." Johnson and Johnson Medical Inc
  2. (2003) "Product Information. Maalox Anti-Gas Extra Strength (simethicone)." Novartis Consumer Health
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  4. Cerner Multum, Inc. "Australian Product Information."
  5. United States National Library of Medicine (2013) Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT

Further information

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