PEPTO RELIEF- bismuth subsalicylate tablet, chewable 
Advance Pharmaceutical Inc.

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.

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PEPTO RELIEF Bismuth Subsalicylate 262 MG

Drug Facts

.

Active Ingredient

(in each tablet)

Bismuth subsalicylate 262 mg

Purpose

Anti-diarrheal/Upset stomach reliever

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

diarrhea lasts more than 2 days

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Other Information

INACTIVE INGREDIENT

calcium carbonate, D&C red # 27 (Al-lake), dextrose, flavor (cherry), magnesium stearate, maltodextrin, silicon dioxide, sorbitol

Questions or Comments

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Call 631-981-4600, 8.30 am – 4.30 pm EST Monday - Friday

Package Label

c247abd4-figure-01
c247abd4-figure-02

NDC: 17714-045-30  – 30 CHEWABLE TABLETS

PEPTO RELIEF 
bismuth subsalicylate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17714-045
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBSALICYLATE262 mg
Inactive Ingredients
Ingredient NameStrength
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
Colorpink (light) Scoreno score
ShapeROUNDSize16mm
FlavorCHERRYImprint Code AP;045
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17714-045-3030 in 1 BOTTLE; Type 0: Not a Combination Product01/09/2002
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33501/09/2002
Labeler - Advance Pharmaceutical Inc. (078301063)
Registrant - Advance Pharmaceutical Inc. (078301063)
Establishment
NameAddressID/FEIBusiness Operations
Advance Pharmaceutical Inc.078301063manufacture(17714-045)

Revised: 12/2017
Document Id: 60f4322f-5cb1-096a-e053-2a91aa0a64eb
Set id: a02babe7-9255-44c7-90e1-b5ad5e59c72a
Version: 2
Effective Time: 20171222
 
Advance Pharmaceutical Inc.