Label: STOMACH RELIEF- bismuth subsalicylate tablet
- NDC Code(s): 37808-346-08
- Packager: H E B
- 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 June 30, 2022
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- Active ingredient (in each caplet)
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)
Stop use and ask a doctor if
- symptoms get worse
- ringing in the ears or loss of hearing occurs
- diarrhea lasts more than 2 days
- do not take more than directed
- swallow with water; do not chew
- drink plenty of clear fluids to help prevent dehydration caused by diarrhea
- adults and children 12 years and over: 2 caplets every ½ to 1 hour as needed. Do not exceed 8 doses (16 caplets) in 24 hours.
- do not use for more than 2 days unless directed by a doctor
- use until diarrhea stops, but not more than 2 days
- children under 12 years: ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
Principal display panel
Compare to Pepto-Bismol® active ingredient*
Bismuth subsalicylate 262 mg
Upset Stomach Reliever/Antidiarrheal
• Upset Stomach
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY
SEAL UNDER CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed
by The Procter & Gamble Company, owner of the
registered trademark Pepto-Bismol®.
MADE WITH PRIDE AND CARE FOR
H-E-B®, SAN ANTONIO, TX 78204
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INGREDIENTS AND APPEARANCE
bismuth subsalicylate tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-346 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBSALICYLATE 262 mg Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE (UNII: H0G9379FGK) STARCH, CORN (UNII: O8232NY3SJ) D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX) D&C RED NO. 30 (UNII: 2S42T2808B) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color pink Score no score Shape OVAL Size 16mm Flavor Imprint Code 44;346 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37808-346-08 1 in 1 CARTON 05/06/2011 1 24 in 1 BOTTLE, PLASTIC; 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 05/06/2011 Labeler - H E B (007924756) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(37808-346) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(37808-346) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 117025878 manufacture(37808-346)