Label: PEPTO-BISMOL- bismuth subsalicylate tablet
- NDC Code(s): 73097-010-02, 73097-010-40, 73097-010-50
- Packager: Savings Distributors LLC
- This is a repackaged label.
- Source NDC Code(s): 58933-477
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated July 25, 2019
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
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.
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
Stop use and ask a doctor if
● symptoms get worse or last more than 2 days
● ringing in the ears or loss of hearing occurs ● diarrhea lasts more than 2 days
● 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
- Package Label
INGREDIENTS AND APPEARANCE
bismuth subsalicylate tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73097-010(NDC:58933-477) 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) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) POVIDONE (UNII: FZ989GH94E) D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX) 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:73097-010-40 20 in 1 CARTON 07/15/2019 1 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:73097-010-02 2 in 1 POUCH; Type 0: Not a Combination Product 07/15/2019 3 NDC:73097-010-50 25 in 1 CARTON 07/15/2019 3 2 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 final part335 07/15/2019 Labeler - Savings Distributors LLC (010527359) Establishment Name Address ID/FEI Business Operations Savings Distributors LLC 010527359 repack(73097-010)