Label: PEPTO-BISMOL CHERRY- bismuth subsalicylate suspension
- NDC Code(s): 37000-439-08, 37000-439-12, 37000-439-16
- Packager: The Procter & Gamble Manufacturing Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 5, 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 30 mL dose)
- Purpose
- 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: Contains salicylate. Do not take if you are
• allergic to salicylates (including aspirin)
• taking other salicylate products - Do not use if you have
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- When using this product
- Stop use and ask a doctor if
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
-
Directions
- shake well before use
- only use dose cup provided
- adults and children 12 years and over:
- 30 mL (1 dose) every ½ hour or 60 mL (2 doses) every hour as needed for diarrhea/traveler's diarrhea
- 30 mL (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
- do not exceed 8 doses (240 mL) 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 - 354 mL Bottle Label
-
INGREDIENTS AND APPEARANCE
PEPTO-BISMOL CHERRY
bismuth subsalicylate suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-439 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE 525 mg in 30 mL Inactive Ingredients Ingredient Name Strength METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H) BENZOIC ACID (UNII: 8SKN0B0MIM) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) D&C RED NO. 22 (UNII: 1678RKX8RT) D&C RED NO. 28 (UNII: 767IP0Y5NH) SUCRALOSE (UNII: 96K6UQ3ZD4) SALICYLIC ACID (UNII: O414PZ4LPZ) SODIUM SALICYLATE (UNII: WIQ1H85SYP) SORBIC ACID (UNII: X045WJ989B) WATER (UNII: 059QF0KO0R) GELLAN GUM (HIGH ACYL) (UNII: W1L7G7ROMD) Product Characteristics Color pink Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37000-439-08 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/01/2018 2 NDC:37000-439-12 354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/01/2018 3 NDC:37000-439-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M008 03/01/2018 Labeler - The Procter & Gamble Manufacturing Company (004238200)