PREMIER VALUE EXTRA STRENGTH- simethicone tablet, chewable

Premier Value by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient (in each tablet)

Simethicone 125 mg

Purpose

Anti-gas

Uses

For the relief of

• ▪ Pressure, bloating and fullness commonly referred to as gas

Warning

Keep Out of Reach of Children

Directions

• adults: chew 1 to 2 tablets as needed after meals and at bedtime.
• do not exceed 4 tablets in a 24 hours except under the advice and supervision of a physician.

Other information

• each tablets contains: calcium 45 mg
• store at room temperature
• protect from excessive heat and moisture

DO NOT USE IF ANY INDVIDUAL BLISTER IS BROKEN OR OPEN

Inactive ingredients

D&C Red No. 30, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sucralose, tribasic calcium phosphate.

Principal Display Panel

Premier Value®

NDC: 68016-811-18

*Compare to the active ingredient in Gas-X® Extra Strength

Extra Strength

Gas Relief

Antigas/Simethicone 125 mg

Relieves:

• Pressure
• Bloating
• Discomfort

Cherry Creme Flavor

Naturally and Artificially Flavored

18 CHEWABLE TABLETS

K PAREVE

*This product is not manufactured or distributed by GSK Consumer Healthcare, Inc. the distributor of Gas-X® Extra strength.

Distributed by:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

IMPORTANT: Keep this carton for future reference on full labeling.

INGREDIENTS AND APPEARANCE

PREMIER VALUE  EXTRA STRENGTH
simethicone tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-811
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	125 mg

Inactive Ingredients
Ingredient Name	Strength
D&C RED NO. 30 (UNII: 2S42T2808B)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)

Product Characteristics
Color	PINK	Score	no score
Shape	ROUND	Size	14mm
Flavor	CHERRY (CREME)	Imprint Code	RP110
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-811-18	2 in 1 CARTON	05/15/2019
1		9 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part332	05/15/2019

Labeler - PHARMACY VALUE ALLIANCE, LLC (101668460)