KROGER EXTRA STRENGTH GAS RELIEF- simethicone antigas tablet, chewable

Kroger Extra Strength by

Drug Labeling and Warnings

Kroger Extra Strength by is a Otc medication manufactured, distributed, or labeled by KROGER COMPANY. 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 swallow tablets whole.
• ▪ 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

TAMPER EVIDENT: 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

NDC: 30142-481-48

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

Extra Strength

Gas Relief

Simethicone//Anti-gas

For Fast Relief of Pressure,

Bloating & Gas Distress

Cherry Creme Flavor

Naturally and Artificially Flavored

48 Chewable Tablets

Distributed by:

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

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

INGREDIENTS AND APPEARANCE

KROGER EXTRA STRENGTH  GAS RELIEF
simethicone antigas tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30142-481
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 (Cherry Creme)	Imprint Code	RP110
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 30142-481-48	12 in 1 CARTON	03/30/2020
1		4 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	03/30/2020

Labeler - KROGER COMPANY (006999528)