Label: BISMUTH SUBSALICYLATE capsule, gelatin coated
- NDC Code(s): 36800-710-24
- Packager: TOPCO ASSOCIATES 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 23, 2022
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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)
Stop use and ask a doctor if
- symptoms get worse or last more than 2 days
- ringing in the ears or loss of hearing occurs
- diarrhea lasts more than 2 days
- swallow with water, do not chew
- adults and children 12 years and over:
- 2 softgels every ½ hour or 4 softgels every hour as needed for
- 2 softgels every ½ hour to 1 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
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
bismuth subsalicylate capsule, gelatin coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-710 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) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) YELLOW WAX (UNII: 2ZA36H0S2V) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) LIGHT MINERAL OIL (UNII: N6K5787QVP) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Product Characteristics Color pink Score no score Shape OVAL (Oblong shaped) Size 21mm Flavor Imprint Code 262 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-710-24 2 in 1 CARTON 02/19/2021 1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part335 02/19/2021 Labeler - TOPCO ASSOCIATES LLC (006935977)