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

Use

for the relief of

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

Warnings

Keep out of reach of children.

Directions

• adults: 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, FD&C blue #1, gelatin, glycerin, peppermint oil, povidone, purified water, sorbitol sorbitan solution, titanium dioxide

Questions?

Call 1-888-423-0139

PRINCIPAL DISPLAY PANEL - 50 Softgel Blister Pack Carton

NDC: 36800-801-67

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

Extra Strength
Gas Relief
Softgels

ANTIGAS / SIMETHICONE 125mg

FAST RELIF OF

• Bloating
• Pressure
• Fullness & Gas

actual size

50 Softgels

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 (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	125 mg

Inactive Ingredients
Ingredient Name	Strength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
PEPPERMINT OIL (UNII: AV092KU4JH)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
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 FINAL	part332	05/01/2021

Labeler - TOPCO ASSOCIATES LLC (006935977)