Label: PEPTO-BISMOL ULTRA- bismuth subsalicylate tablet
- NDC Code(s): 58933-478-12, 58933-478-24
- Packager: Procter & Gamble Manufactura, S. de R.L. de C.V.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 6, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each caplet)
- 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.
- 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
- swallow with water, do not chew
- adults and children 12 years and over:
- 1 caplet (1 dose) every ½ hour or 2 caplets (2 doses) every hour as needed for diarrhea
- 1 caplet (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
- do not exceed 8 doses (8 caplets) 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
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 12 Caplet Carton
-
INGREDIENTS AND APPEARANCE
PEPTO-BISMOL ULTRA
bismuth subsalicylate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58933-478 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 Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYSORBATE 80 (UNII: 6OZP39ZG8H) CALCIUM CARBONATE (UNII: H0G9379FGK) POVIDONE (UNII: FZ989GH94E) D&C RED NO. 27 (UNII: 2LRS185U6K) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color pink Score no score Shape OVAL (Caplet) Size 18mm Flavor Imprint Code Pepto Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58933-478-24 1 in 1 CARTON 02/01/2018 1 24 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:58933-478-12 1 in 1 CARTON 02/01/2018 2 12 in 1 BOTTLE; 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 02/01/2018 Labeler - Procter & Gamble Manufactura, S. de R.L. de C.V. (812807550)