Label: TOPCO STOMACH RELIEF- bismuth subsalicylate tablet
- NDC Code(s): 36800-104-28
- 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.
Drug Label Information
Updated November 28, 2022
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT(in each caplet)
- PURPOSE
- USE(S)
-
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 behaviour 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
- WHEN USING THIS PRODUCT
- STOP USE AND ASK DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN
-
DIRECTIONS
- swallow caplet(s) with water, do not chew
- adults and children 12 years and over: 2 caplets every 1/2 to 1 hour as needed
- do not take more than 8 doses (16 tablets) 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
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
TOPCO STOMACH RELIEF
bismuth subsalicylate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-104 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 CALCIUM CARBONATE (UNII: H0G9379FGK) D&C RED NO. 27 (UNII: 2LRS185U6K) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color PINK Score no score Shape CAPSULE Size 17mm Flavor Imprint Code G;172 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-104-28 1 in 1 CARTON 10/01/2020 1 40 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 FINAL part335 10/01/2020 Labeler - Topco Associates, LLC (006935977) Establishment Name Address ID/FEI Business Operations Guardian Drug Company 119210276 MANUFACTURE(36800-104)