Label: BISMUTH SUBSALICYLATE 262 MG- bismuth subsalicylate tablet, chewable
- NDC Code(s): 69618-029-03
- Packager: Reliable 1 Laboratories LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 29, 2023
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
- Purposes
- Uses
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Warnings
Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.
- SPL UNCLASSIFIED SECTION
- DO NOT USE
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BISMUTH SUBSALICYLATE 262 MG
bismuth subsalicylate tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69618-029 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE, SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE 262 mg Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE (UNII: H0G9379FGK) DEXTROSE (UNII: IY9XDZ35W2) CHERRY (UNII: BUC5I9595W) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) D&C RED NO. 27 (UNII: 2LRS185U6K) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SORBITOL (UNII: 506T60A25R) Product Characteristics Color pink Score no score Shape ROUND Size 16mm Flavor CHERRY Imprint Code AP;045 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69618-029-03 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part335 11/01/2015 Labeler - Reliable 1 Laboratories LLC (079718111) Registrant - Reliable 1 Laboratories LLC (079718111)