STOMACH RELIEF- bismuth subsalicylate tablet 
CDMA- QC

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

Active ingredient(s)

Bismuth subsalicylate 262mg (each tablet contains 102mg salicylate)

Purpose

Antidiarrheal/Antacid

Use(s)

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

  • an ulcer
  • a bleeding problem
  • bloody or black stool

Ask a doctor before use if

  • fever
  • mucus in the stool

Ask a doctor or pharmacist before use if

you are taking any drug for

  • anticoagulation (thinning of 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

Pregnancy/Breastfeeding

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

Keep out of reach of children

In case of accidental overdose, get medical help or contact a Poison Control Center
(1-800-222-1222) right away.

Directions

Chew or dissolve in mouth

Adults and children 12 years and over:

Children under 12 years of age: ask a doctor

Other information

Phenylketonurics: contains phenylalanine 1.1mg per tablet Calcium content per tablet: 73mg

Do not use if cellophane unit is torn

Storage

Store at room temperature 15°– 30°C (59°– 86°F)

Inactive ingredients

acacia gum, aspartame, calcium carbonate, D&C red #27 aluminum
lake, dextrates, magnesium stearate, maltodextrin, microcrystalline cellulose, peppermint flavor, silicon dioxide

Principal Display Panel

Stomach Relief

Stomach Relief


STOMACH RELIEF 
bismuth subsalicylate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-622
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
ASPARTAME (UNII: Z0H242BBR1)  
ACACIA (UNII: 5C5403N26O)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
DEXTRATES (UNII: G263MI44RU)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
PEPPERMINT (UNII: V95R5KMY2B)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorpinkScoreno score
ShapeROUNDSize17mm
FlavorImprint Code RH046
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-622-3030 in 1 CELLO PACK; Type 0: Not a Combination Product06/16/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33512/23/2014
Labeler - CDMA- QC (011920774)

Revised: 6/2021
Document Id: 685b6cb2-59a8-456a-b55d-8f18b42c3453
Set id: fe3cd0ce-933b-4ad3-a34f-c057a9356158
Version: 1
Effective Time: 20210616
 
CDMA- QC