Label: LEADER STOMACH RELIEF ORIGINAL STRENGTH- bismuth subsalicylate tablet, chewable
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Contains inactivated NDC Code(s)
NDC Code(s): 37205-720-65 - Packager: Cardinal Health
- 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.
Drug Label Information
Updated January 22, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- 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
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- allergic to salicylates (including aspirin)
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- taking other salicylate products
Ask a doctor or pharmacist before use if you are
taking any drug for
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- anticoagulation (thinning the blood)
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- diabetes
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- gout
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- arthritis
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Directions
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- chew or dissolve tablets in mouth
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- drink plenty of clear fluids to help prevent dehydration caused by diarrhea
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- adults and children 12 years and older: 2 tablets every ½ to 1 hour, or 4 tablets every hour as needed
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- do not exceed 16 tablets in 24 hours
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- use until diarrhea stops but not more than 2 days
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- children under 12 years: ask a doctor
- Other information
- Inactive ingredients
- Questions?
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Principal Display Panel
LEADER
NDC 37205-720-65
Compare to Pepto-Bismol® active ingredient*
Pink Bismuth
Chewable Tablets
Bismuth Subsalicylate 262 mg
Original Flavor
Provides Soothing Relief for:
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- Indigestion
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- Upset Stomach
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- Nausea
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- Diarrhea
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- Heartburn
SATISFACTION GUARANTEED
30 CHEWABLE TABLETS
All Leader® Brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund.
Distributed By: Cardinal Health
Dublin, Ohio 43017
CIN 2572691
*This product is not manufactured or distributed by Procter & Gamble Inc., the distributor of PEPTO-BISMOL®.
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INGREDIENTS AND APPEARANCE
LEADER STOMACH RELIEF ORIGINAL STRENGTH
bismuth subsalicylate tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37205-720 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 MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) D&C RED NO. 27 (UNII: 2LRS185U6K) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color PINK Score no score Shape ROUND Size 17mm Flavor Imprint Code L469 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37205-720-65 5 in 1 CARTON 08/20/2019 1 6 in 1 BLISTER PACK; 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 08/20/2019 Labeler - Cardinal Health (097537435)