QC ANTI DIARRHEAL VANILLA REGULAR FLAVOR- bismuth subsalicylate suspension 
QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)

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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Quality Choice Diarrhea Relief Bismuth Subsalicylate Vanilla Regular Flavor

Drug Facts

Active ingredient (per 15 ml)

Bismuth subsalicylate 262 mg

Purposes

Antidiarrheal/Upset stomach reliever

Uses

Relieves

▪
traveler’s diarrhea
▪
diarrhea
▪
upset stomach due to overindulgence in food and drink
▪
heartburn
▪
indigestion
▪
nausea
▪
gas

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
▪
gout
▪
arthritis
▪
anticoagulation (thinning the blood)

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 at 1-800-222-1222.

Directions

▪
shake well immediately before each use
▪
adults and children 12 years of age and older : 30 ml or 2 tablespoonful
▪
for accurate dosing, use convenient pre-measured dose cup
▪
repeat dose every 1/2 hour to 1 hour as needed
▪
do not exceed 8 doses in 24 hours
▪
use until diarrhea stops but not more than 2 days
▪
children under 12 years: ask a doctor
▪
drink plenty of clear fluids to help prevent dehydration caused by diarrhea

Other information

▪
each 15mL tablespoon contains: sodium 10 mg
▪
each 15mL tablespoon contains: salicylate 130 mg
▪
do not use if printed inner seal is broken or missing
▪
store at room temperature

Inactive ingredients

caramel, carboxymethylcellulose sodium, microcrystalline cellulose, natural and artificial flavor, potassium sorbate, salicylic acid , simethicone emulsion, sucralose, sucrose, water, xanthan gum

Questions or comments?

1-866-467-2748

PRINCIPAL DISPLAY PANEL - 355 mL Bottle Label

NDC 63868-339-12

Compare to the active ingredient in Kaopectate®

Diarrhea Relief

Bismuth Subsalicylate, 262 mg

Bismuth Subsalicylate, 262 mg

Antidiarrheal

Upset Stomach Reliever

Effective Diarrhea Relief

Restores Natural Balance

 
Vanilla Regular Flavor

12 FL OZ (355 mL)

100% SATISFACTION GUARANTEED

Distributed by: C.D.M.A., Inc.

43157 W. Nine Mile

Novi. MI 48376-0995

www.qualitychoice.com

Question: 248-449-9300

*This product is not manufactured or distributed by Chattem Inc., the distributor of Kaopectate ®.

QC(CDMA) Bismuth Subsalicylate Diarrhea Relief
QC ANTI DIARRHEAL  VANILLA REGULAR FLAVOR
bismuth subsalicylate suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-339
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  in 15 mL
Inactive Ingredients
Ingredient NameStrength
CARAMEL (UNII: T9D99G2B1R)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
salicylic acid (UNII: O414PZ4LPZ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SUCROSE (UNII: C151H8M554)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorVANILLA (Regular) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-339-12355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/16/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33504/16/2019
Labeler - QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) (011920774)

Revised: 1/2021
Document Id: bb5f60c5-5995-4c28-bfb0-41e1a3e6e372
Set id: 02737763-eb98-401d-942c-186c401a2d31
Version: 2
Effective Time: 20210121
 
QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)