Label: STOMACH RELIEF- bismuth subsalicylate tablet, chewable
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Contains inactivated NDC Code(s)
NDC Code(s): 66424-045-30 - Packager: SDA Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
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 August 3, 2013
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- Active Ingredient (in each tablet)
- Purposes
- 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 symtoms could be an early sign of Reye's syndrome, a rare but serious illness.
Allergy alert: 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
talking any drug for
- anticoagulation (thinning the blood)
- diabetes
- gout
- arthritis
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
NDC 66424-045-30
Stomach Relief
Bismuth Subsalicylate 262 mg
Anti-Diarrheal/ Upset Stomach Reliever
Helps to Relieve:
- Upset Stomach
- Diarrhea
- Indigestion
- Heartburn
- Nausea
†Compare to the Active Ingredients in Pepto-Bismol
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING
†This product is not manufactured or distributed by Proctor & Gamble, owner of the registered trademark Pepto-Bismol
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INGREDIENTS AND APPEARANCE
STOMACH RELIEF
bismuth subsalicylate tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66424-045 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBSALICYLATE 262 mg Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE (UNII: H0G9379FGK) D&C RED NO. 27 (UNII: 2LRS185U6K) DEXTROSE (UNII: IY9XDZ35W2) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SORBITOL (UNII: 506T60A25R) Product Characteristics Color pink (light) Score no score Shape ROUND Size 16mm Flavor CHERRY Imprint Code AP;045 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66424-045-30 30 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part335 09/27/2012 Labeler - SDA Laboratories, Inc. (948067889)