PREMIER VALUE DIARRHEA RELIEF VANILLA FLAVOR- bismuth subsalicylate suspension

Premier Value Diarrhea Relief by

Drug Labeling and Warnings

Premier Value Diarrhea Relief by is a Otc medication manufactured, distributed, or labeled by PHARMACY VALUE ALLIANCE, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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®.

INGREDIENTS AND APPEARANCE

PREMIER VALUE DIARRHEA RELIEF  VANILLA FLAVOR
bismuth subsalicylate suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-317
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Bismuth subsalicylate (UNII: 62TEY51RR1) (Salicylic acid - UNII:O414PZ4LPZ, Bismuth cation - UNII:ZS9CD1I8YE)	Bismuth subsalicylate	262 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score
Shape		Size
Flavor	VANILLA	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-317-12	355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/23/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part335	04/23/2019

Labeler - PHARMACY VALUE ALLIANCE, LLC (101668460)