TOPCARE EXTRA STRENGTH GAS RELIEF CHERRY CREME- simethicone tablet, chewable

TopCare Extra Strength Gas Relief by

Drug Labeling and Warnings

TopCare Extra Strength Gas Relief by is a Otc medication manufactured, distributed, or labeled by TOPCO ASSOCIATES LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Simethicone 125 mg

Purpose

Anti-gas

Uses

Foe the relief of

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

Warnings

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 24 hour except under the advice and supervision of a physician

Other information

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

Inactive ingredients

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

Questions or comments?

1-866-467-2748

Principal Display Panel

NDC: 36800-488-48

Compare to the active ingredientGas-X® Extra Strength

Extra Strength

Gas Relief

Simethicone 125 mg/ Antigas

•   For Fast Relief of Pressure, Bloating & Discomfort

Cherry Creme Flavor

Naturally and Artificially Flavored

48 CHEWABLE TABLETS

DO NOT USE IF PRINTED INNER SEAL IS BROKEN OR MISSING

DISTRIBUTED BY: TOPCO ASSOCIATES LLC,

ELK GROVE VILLAGE, IL 60007

© TOPCO RARA1217

QUESTIONS? 1-888-423-0139

topcare@topco.com, www.topcarebrand.com

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

INGREDIENTS AND APPEARANCE

TOPCARE EXTRA STRENGTH GAS RELIEF  CHERRY CREME
simethicone tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-488
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: 36800-488-48	48 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/07/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part332	03/07/2019

Labeler - TOPCO ASSOCIATES LLC (006935977)