Label: PEPTO BISMOL CHEWS- bismuth subsalicylate tablet, chewable
- NDC Code(s): 69423-963-24, 69423-963-72
- 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)
- 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:
- 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 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, FD&C Blue No. 2 Aluminum Lake, 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 Chewable Tablets
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INGREDIENTS AND APPEARANCE
PEPTO BISMOL CHEWS
bismuth subsalicylate tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69423-963 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 FD&C BLUE NO. 2 ALUMINUM LAKE (UNII: 4AQJ3LG584) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBIC ACID (UNII: X045WJ989B) SORBITOL (UNII: 506T60A25R) ICODEXTRIN (UNII: 2NX48Z0A9G) ACACIA (UNII: 5C5403N26O) YELLOW WAX (UNII: 2ZA36H0S2V) CALCIUM CARBONATE (UNII: H0G9379FGK) HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CARNAUBA WAX (UNII: R12CBM0EIZ) STARCH, CORN (UNII: O8232NY3SJ) CORN SYRUP (UNII: 9G5L16BK6N) MALTODEXTRIN (UNII: 7CVR7L4A2D) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) SHELLAC (UNII: 46N107B71O) SODIUM BENZOATE (UNII: OJ245FE5EU) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SUCROSE (UNII: C151H8M554) CARMINIC ACID (UNII: CID8Z8N95N) WATER (UNII: 059QF0KO0R) 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:69423-963-24 24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/01/2020 2 NDC:69423-963-72 72 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)
