Label: PEPTO BISMOL CHEWS- bismuth subsalicylate tablet, chewable
- NDC Code(s): 37000-996-24, 37000-996-72
- Packager: The Procter & Gamble Manufacturing Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 6, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each chewable tablet)
- Purposes
- Uses
-
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:
- DO NOT USE
- Ask a doctor before use if you have
- ASK DOCTOR/PHARMACIST
- When using this product
- Stop use and ask a doctor if
- If pregnant or breast feeding,
- KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
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Directions
- fully chew before swallowing
- adults and children 12 years and over:
- 2 chewable tablets every ½ hour or 4 chewable tablets every hour as needed for diarrhea
- 2 chewable tablets every ½ hour to 1 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
- do not exceed 8 doses (16 chewable 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
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Inactive ingredients
acacia, beeswax, calcium carbonate, caprylic/capric triglyceride, carmine, carnauba wax, citric acid, corn starch, corn syrup, dextrin, flavor, hydrogenated coconut oil, maltodextrin, potassium hydroxide, propylene glycol, shellac, sodium benzoate, sorbic acid, sorbitol, soy lecithin, sucrose, titanium dioxide, water
- Questions?
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 24 Tablet Carton
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INGREDIENTS AND APPEARANCE
PEPTO BISMOL CHEWS
bismuth subsalicylate tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-996 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 WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBIC ACID (UNII: X045WJ989B) HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM) SORBITOL (UNII: 506T60A25R) ICODEXTRIN (UNII: 2NX48Z0A9G) ACACIA (UNII: 5C5403N26O) YELLOW WAX (UNII: 2ZA36H0S2V) CALCIUM CARBONATE (UNII: H0G9379FGK) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CARNAUBA WAX (UNII: R12CBM0EIZ) STARCH, CORN (UNII: O8232NY3SJ) CORN SYRUP (UNII: 9G5L16BK6N) SODIUM BENZOATE (UNII: OJ245FE5EU) MALTODEXTRIN (UNII: 7CVR7L4A2D) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) SHELLAC (UNII: 46N107B71O) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CARMINIC ACID (UNII: CID8Z8N95N) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SUCROSE (UNII: C151H8M554) Product Characteristics Color pink Score no score Shape ROUND Size 18mm Flavor WINTERGREEN Imprint Code PB Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37000-996-24 24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/01/2020 2 NDC:37000-996-72 3 in 1 CELLO PACK 09/01/2020 2 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 Drug M008 09/01/2020 Labeler - The Procter & Gamble Manufacturing Company (004238200)
