Label: PEPTO BISMOL- bismuth subsalicylate tablet, chewable
- NDC Code(s): 67751-155-01, 67751-155-02
- Packager: Navajo Manufacturing Company Inc.
- This is a repackaged label.
- Source NDC Code(s): 58933-011
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 15, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient (in each Chewable tablet)
- 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 productsAsk a doctor or pharmacist before use if you are taking any drug for
• anticoagulation (thinning the blood)
• diabetes
• gout
• arthritis -
Directions
• chew or dissolve in mouth
• adults and children 12 years and over:• 2 tablets every 1/2 to 1 hour as needed
• do not exceed 8 doses (16 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
- Inactive ingredients
- Questions?
- Package Labeling:
-
INGREDIENTS AND APPEARANCE
PEPTO BISMOL
bismuth subsalicylate tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67751-155(NDC:58933-011) 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 CALCIUM CARBONATE (UNII: H0G9379FGK) D&C RED NO. 27 (UNII: 2LRS185U6K) ALUMINUM OXIDE (UNII: LMI26O6933) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) POVIDONE (UNII: FZ989GH94E) SACCHARIN SODIUM (UNII: SB8ZUX40TY) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color pink Score no score Shape ROUND Size 16mm Flavor WINTERGREEN Imprint Code Pepto;Bismol Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67751-155-01 1 in 1 CARTON 09/20/2016 1 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:67751-155-02 1 in 1 CARTON 09/20/2016 2 4 in 1 POUCH; 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 09/20/2016 Labeler - Navajo Manufacturing Company Inc. (091917799) Establishment Name Address ID/FEI Business Operations Navajo Manufacturing Company Inc. 136941411 repack(67751-155) , relabel(67751-155)
