PREMIER VALUE DIARRHEA RELIEF VANILLA FLAVOR- bismuth subsalicylate suspension 
PHARMACY VALUE ALLIANCE, LLC

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Premier Value Diarrheal Relief

Drug Facts

Active Ingredient (per 15 mL)

Bismuth Subsalicylate 262 mg

Purposes

Anti-diarrheal/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

a sodium-restricted diet
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

Premier Value®

NDC 68016-317-12

COMPARE TO THE ACTIVE INGREDIENT IN KAOPECTATE®

Diarrhea Relief

VANILLA

Regular flavor

Bismuth Subsalicylate, 262 mg

Anti-Diarrheal
Upset Stomach Reliever

Effective Diarrhea Relief

Restores Natural Balance

Contains Salicylates

12 FL OZ (355 mL)

Distributed by:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

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

Premier Value Diarrhea Relief Vanilla Flavor
PREMIER VALUE DIARRHEA RELIEF  VANILLA FLAVOR
bismuth subsalicylate suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-317
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 (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
FlavorVANILLAImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-317-12355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/23/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00804/23/2019
Labeler - PHARMACY VALUE ALLIANCE, LLC (101668460)

Revised: 11/2023
Document Id: 875b6f6b-23ac-460c-a6ab-ad1c5ef1edc9
Set id: 1c6e464c-d5c6-4658-a0d8-bba87369a0c3
Version: 5
Effective Time: 20231106
 
PHARMACY VALUE ALLIANCE, LLC