STOMACH RELIEF- bismuth subsalicylate tablet 
CHAIN DRUG MARKETING ASSOCIATION 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.

----------

Quality Choice 44-346

Active ingredient (in each caplet)

Bismuth subsalicylate 262 mg

Purpose

Upset stomach reliever/antidiarrheal 

Uses

relieves:

  • travelers' diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink, including:
    • belching
    • indigestion
    • gas
    • fullness
    • heartburn
    • nausea

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:

  • allergic to salicylates (including aspirin) 
  • taking other salicylate products

Do not use

if you have

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

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

  • diabetes
  • arthritis
  • anticoagulation (thinning the blood)
  • gout

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. 

Keep out of reach of children.

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

Directions

  • do not take more than directed
  • swallow with water; do not chew
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • adults and children 12 years and over: 2 caplets every 1/2 to 1 hour as needed. Do not exceed 8 doses (16 caplets) in 24 hours.
  • do not use for more than 2 days unless directed by a doctor
  • use until diarrhea stops, but not more than 2 days
  • children under 12 years: ask a doctor

Other information

  • each caplet contains: calcium 20 mg, salicylate 103 mg
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • avoid excessive heat
  • see end flap for expiration date and lot number 

Inactive ingredients

calcium carbonate, corn starch, D&C red #27 aluminum lake, D&C red #30 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate, stearic acid

Questions or comments?

1-800-426-9391

Principal display panel

QC® 
QUALITY
CHOICE

NDC 63868-691-40

*Compare to the
Active Ingredient in
Pepto-Bismol®

Stomach Relief
Bismuth Subsalicylate 262 mg
Upset Stomach Reliever/Antidiarrheal

Relieves Nausea, Heartburn, Indigestion,
Upset Stomach, Diarrhea

actual size

40 Caplets

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

*This product is not manufactured or distributed by The
Procter & Gamble Company, owner of the registered
trademark Pepto-Bismol®.
50844 REV0521A34610

SATISFACTION
GUARANTEED
100% QC

Distributed by C.D.M.A., Inc.©
43157 W 9 Mile Rd
Novi, MI 48375
www.qualitychoice.com
Questions: 800-935-2362

Quality Choice 44-346

Quality Choice 44-346

STOMACH RELIEF 
bismuth subsalicylate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-691
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBSALICYLATE262 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
STARCH, CORN (UNII: O8232NY3SJ)  
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorpinkScoreno score
ShapeOVALSize16mm
FlavorImprint Code 44;346
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-691-401 in 1 CARTON03/31/2021
140 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33503/31/2021
Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464pack(63868-691)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894manufacture(63868-691)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.117025878manufacture(63868-691)

Revised: 9/2022
Document Id: 2ce9d01e-aefe-46fd-a6bc-7321dc8c6c2d
Set id: e1552f01-ab98-41c7-a7be-aedf2d40e437
Version: 3
Effective Time: 20220921
 
CHAIN DRUG MARKETING ASSOCIATION INC