Label: STOMACH RELIEF- bismuth subsalicylate capsule, liquid filled
- NDC Code(s): 68210-4238-5
- Packager: Spirit Pharmaceuticals 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.
Updated November 17, 2022
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- Drug Facts
- Active Ingredient (in each tablet)
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.
• 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
- Questions or comments?
- Principal Display Panel
INGREDIENTS AND APPEARANCE
bismuth subsalicylate capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-4238 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:68210-4238-5 60 in 1 POUCH; Type 0: Not a Combination Product 11/17/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part335 11/17/2022 Labeler - Spirit Pharmaceuticals LLC (179621011)