Label: PEPTO-BISMOL- bismuth subsalicylate tablet
- NDC Code(s): 58933-476-01, 58933-476-02, 58933-476-03, 58933-476-12
- Packager: Procter & Gamble Manufactura S de RL de CV
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated October 10, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each caplet)
- 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
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Directions
• swallow with water, do not chew
• adults and children 12 years and over:- 2 caplets (1 dose) every ½ hour or 4 caplets (2 doses) every hour as needed for diarrhea
- 2 caplets (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
• do not exceed 8 doses (16 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 - 24 Caplet Carton
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INGREDIENTS AND APPEARANCE
PEPTO-BISMOL
bismuth subsalicylate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58933-476 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 D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX) CALCIUM CARBONATE (UNII: H0G9379FGK) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color pink Score no score Shape OVAL (Caplet) Size 16mm Flavor Imprint Code PeptoBismol Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58933-476-01 1 in 1 POUCH 06/30/2004 1 2 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:58933-476-02 1 in 1 CARTON 06/30/2004 2 24 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:58933-476-03 1 in 1 CARTON 06/30/2004 3 40 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:58933-476-12 17852 in 1 BAG; Type 0: Not a Combination Product 06/30/2004 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M008 06/30/2004 Labeler - Procter & Gamble Manufactura S de RL de CV (812807550)