GAS RELIEF- simethicone capsule, liquid filled

Gas Relief by

Drug Labeling and Warnings

Gas Relief by is a Otc medication manufactured, distributed, or labeled by Advanced Rx LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

If pregnant or breast-feeding,ask a health professional before use.

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 at 20° to 25°C (68° to 77°F)
• protect from light, heat and moisture
• DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

Inactive ingredients

FD&C blue #1, FD&C yellow #10, gelatin, glycerin, peppermint oil, povidone, purified water, sorbitol 70% solution, titanium dioxide.

Questions?

call 1-800-630-8895

SPL UNCLASSIFIED SECTION

Distributed by:

Advanced Rx LLC

1942 NE 163rd St North Miami Beach,

FL 33162 U.S.A.

PRINCIPAL DISPLAY PANEL

NDC: 80513-111-12

EXTRA STRENGTH

GAS RELIEF

Simethicone 125 mg

RELIEVES GAS FAST

PRESSURE

BLOATING

DISCOMFORT

120 SOFTGELS

INGREDIENTS AND APPEARANCE

GAS RELIEF 
simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80513-111
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
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
PEPPERMINT OIL (UNII: AV092KU4JH)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	green	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	YH3
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80513-111-12	120 in 1 BOTTLE; Type 0: Not a Combination Product	08/30/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M002	08/30/2024

Labeler - Advanced Rx LLC (042795108)