Label: STOMACH RELIEF- bismuth subsalicylate capsule, liquid filled
- NDC Code(s): 68210-4228-5
- Packager: Spirit Pharmaceuticals LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 6, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient (in each tablet)
- Purpose
- 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.
Allergy alert: Contains salicylate.
Do not take if you are • allergic to salicylates (including aspirin) • taking other salicylate products - Do not use if you have
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use if you are if you are
- When using this product
- If pregnant or breast-feeding,
- Keep out of reach of children.
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Directions
• swallow with water, do not chew • adults and children 12 years and over: • 2 softgels (1 dose) every 1/2 hour or 4 softgels (2 doses) every hour as needed for diarrhea • 2 soft gels (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) • do not exceed 8 doses (16 softgels) in 24 hours • use until diarrhea stops but not more than 2 days • children under 12 years: ask a doctor • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
- Other information
- Inactive ingredients
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INGREDIENTS AND APPEARANCE
STOMACH RELIEF
bismuth subsalicylate capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-4228 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE 262 mg Inactive Ingredients Ingredient Name Strength SYNTHETIC BEESWAX (UNII: 08MNR5YE2R) SILICON (UNII: Z4152N8IUI) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) PARAFFIN (UNII: I9O0E3H2ZE) WATER (UNII: 059QF0KO0R) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1) SORBITOL SOLUTION (UNII: 8KW3E207O2) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color pink Score no score Shape CAPSULE Size 14mm Flavor Imprint Code 262 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68210-4228-5 60 in 1 JAR; Type 0: Not a Combination Product 11/15/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M008 11/15/2022 Labeler - Spirit Pharmaceuticals LLC (179621011)