Label: PEPTO BISMOL- bismuth subsalicylate tablet, chewable
- NDC Code(s): 29485-1531-4, 29485-6754-6
- Packager: Lil' Drug Store Products, Inc.
- Category: HUMAN OTC DRUG LABEL
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 July 19, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient(in each tablet)
- Purpose
- 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
When using this product a temporary, but harmless, darkening of the stool and/or
tongue may occur -
Directions
- chew or dissolve in mouth
- adults and children 12 years and over: 2 tablets (1 dose) every 1/2 hour or 4 tablets (2 doses) every hour as needed for diarrhea
- 2 tablets (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
- do not exceed 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
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
PEPTO BISMOL
bismuth subsalicylate tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:29485-1531 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 MANNITOL (UNII: 3OWL53L36A) TALC (UNII: 7SEV7J4R1U) CALCIUM CARBONATE (UNII: H0G9379FGK) MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Product Characteristics Color pink Score no score Shape ROUND Size 16mm Flavor WINTERGREEN Imprint Code Pepto;Bismol Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:29485-1531-4 2 in 1 BLISTER PACK 04/30/2002 11/03/2025 1 2 in 1 CELLO 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 M001 04/30/2002 11/03/2025 PEPTO BISMOL
bismuth subsalicylate tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:29485-6754 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 MANNITOL (UNII: 3OWL53L36A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SACCHARIN SODIUM (UNII: SB8ZUX40TY) TALC (UNII: 7SEV7J4R1U) CALCIUM CARBONATE (UNII: H0G9379FGK) D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX) Product Characteristics Color pink Score no score Shape ROUND Size 16mm Flavor WINTERGREEN Imprint Code Pepto;Bismol Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:29485-6754-6 3 in 1 BLISTER PACK 02/06/2017 10/13/2025 1 2 in 1 CELLO 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 M001 02/06/2017 10/13/2025 Labeler - Lil' Drug Store Products, Inc. (093103646)