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
Drug Label Information
Updated January 15, 2025
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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 Drug M008 11/01/2015 Labeler - Reliable 1 Laboratories LLC (079718111) Registrant - Reliable 1 Laboratories LLC (079718111)