STOMACH RELIEF- bismuth subsalicylate tablet, chewable 
PuraCap Pharmaceutical LLC

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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Stomach Relief

Drug Facts

Active Ingredient (in each tablet)

Bismuth subsalicylate 262 mg

Purposes

Upset stomach reliever and antidiarrheal

Uses

relieves

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

Do not use if you have

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are taking any drug for

When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur

Stop use and ask a doctor if

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 ingredients

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

Questions or comments

Call toll free: 1-855-215-8180

PRINCIPAL DISPLAY PANEL

Stomach Relief

30 Tablets   15 Pouches (2 Tablets per Pouch)

NDC: 51013-321-54

CVSF34-00

CVSB34-00

STOMACH RELIEF 
bismuth subsalicylate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51013-321
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:51013-321-5415 in 1 CARTON11/28/2017
12 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33511/28/2017
Labeler - PuraCap Pharmaceutical LLC (962106329)
Establishment
NameAddressID/FEIBusiness Operations
Advance Pharmaceutical Inc.078301063MANUFACTURE(51013-321)

Revised: 11/2017
Document Id: 841fb60d-9e76-4a46-8905-7de3f25b6788
Set id: 01a4782f-93af-4d30-8ca3-7b39c272f60e
Version: 1
Effective Time: 20171128
 
PuraCap Pharmaceutical LLC