Citric acid / potassium bicarbonate / sodium bicarbonate Pregnancy and Breastfeeding Warnings
Brand names: Alka-Seltzer Gold
Citric acid / potassium bicarbonate / sodium bicarbonate Pregnancy Warnings
Safety has not been established during pregnancy.
US FDA pregnancy category: Not assigned.
Risk summary: No data available on use of this drug in pregnant women to inform a drug-related risk.
Comment: The manufacturer recommends that patients should ask their health care providers before use during pregnancy.
Animal studies have not been reported. There are no controlled data in human pregnancy.
US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.
Citric acid / potassium bicarbonate / sodium bicarbonate Breastfeeding Warnings
Safety has not been established.
Excreted into human milk: Data not available
Excreted into animal milk: Data not available
Comments:
-The WHO classifies sodium bicarbonate as compatible with breastfeeding.
-The manufacturer recommends that patients ask their health care provider before use during lactation.
References for pregnancy information
- (2022) "Product Information. Alka-Seltzer Gold (citric acid/potassium bicarbonate/Na bicarb)." Bayer Pharmaceutical Inc
References for breastfeeding information
- 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
- (2022) "Product Information. Alka-Seltzer Gold (citric acid/potassium bicarbonate/Na bicarb)." Bayer Pharmaceutical Inc
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.