Label: PEPTO RELIEF- bismuth subsalicylate tablet, chewable
- NDC Code(s): 54738-102-30, 54738-102-48
- Packager: Richmond Pharmaceuticals, Inc
- 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 October 30, 2017
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
- Purpose
- Uses
-
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: Do not take if you are
- allergic to salicylates (including aspirin)
- taking other salicylate products
Do not use
- If you have bloody or black stool
- If you have an ulcer or bleeding problem
Ask a doctor before use if you have
- Fever
- Mucus in the stool
Ask a doctor or pharmacist before use if you are
- taking any drug for
- anticoagulation (thinning the blood)
- diabetes
- gout
- arthritis
when using this product a temporary, but harmless, darkening of the stool and/or tongue may occur
stop use and ask a doctor if
- symptoms get worse
- ringing in the ears or loss of hearing occurs
diarrhea lasts more than 2 days
If pregnant or breast-feeding, ask a health professional before use.
- Directions
- Other Information
- INACTIVE INGREDIENT
- Questions or Comments
- Package Label
-
INGREDIENTS AND APPEARANCE
PEPTO RELIEF
bismuth subsalicylate tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54738-102 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) CHERRY (UNII: BUC5I9595W) 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:54738-102-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2015 2 NDC:54738-102-48 48 in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part335 06/01/2015 Labeler - Richmond Pharmaceuticals, Inc (043569607) Registrant - Advance Pharmaceutical Inc. (078301063) Establishment Name Address ID/FEI Business Operations Advance Pharmaceutical Inc. 078301063 manufacture(54738-102)
