GAS RELIEF EXTRA STRENGTH- dimethicone capsule, liquid filled

Gas Relief Extra Strength by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each softgel)

Simethicone 125 mg

Purpose

Antigas

Uses

for the relief of
Pressure, bloating, and fullness commonly referred to as gas

Warnings

Keep out of reach of children.

Directions

• adults and children 12 years and older: swallow with water 1 or 2 softgels as needed after meals and at bedtime
• do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician

Other information

• store between 20-25°C (68-77°F)
• protect from heat and moisture

Inactive ingredients

D&C yellow #10, edible white ink, FD&C blue #1, FD&C red #40, gelatin. glycerin, light mineral oil, peppermint oil, purified water, titanium dioxide

Questions?

Call 1-888-423-0139

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TopCare® health

COMPARE TO GAS-X® EXTRA STRENGTH ACTIVE INGREDIENT*

FAST RELIEF OF:

• Bloating
• Pressure
• Fullness & Gas

DISTRIBUTED BY TOPCO ASSOCIATES LLC,
ELK GROVE VILLAGE, IL 60007
©TOPCO STVA0122
topcare@topco.com www.topcarebrand.com

This TopCare® product is laboratory tested to guarantee its highest quality. Your total satisfaction is guaranteed.

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

TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

KEEP OUTER CARTON FOR COMPLETE PRODUCT INFORMATION

Packaging

INGREDIENTS AND APPEARANCE

GAS RELIEF EXTRA STRENGTH 
dimethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-785
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
PEPPERMINT OIL (UNII: AV092KU4JH)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	GREEN	Score	no score
Shape	OVAL	Size	9mm
Flavor		Imprint Code	791
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-785-05	2 in 1 CARTON	05/01/2021
1		25 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 Drug	M002	05/01/2021

Labeler - TOPCO ASSOCIATES LLC (006935977)