Label: STOMACH RELIEF- bismuth subsalicylate capsule, liquid filled
- NDC Code(s): 68210-0469-3
- Packager: Spirit Pharmaceuticals LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 11, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- 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
Ask a doctor or pharmacist before use if you are taking any drug for
- anticoagulation (thinning the blood)
- diabetes
- gout
- arthritis
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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 softgels (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
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
STOMACH RELIEF
bismuth subsalicylate capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-0469 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) YELLOW WAX (UNII: 2ZA36H0S2V) 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) SORBITOL (UNII: 506T60A25R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color pink Score no score Shape CAPSULE Size 18mm Flavor Imprint Code 854 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68210-0469-3 1 in 1 CARTON 06/28/2019 1 30 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M008 06/28/2019 Labeler - Spirit Pharmaceuticals LLC (179621011)