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, ELYSIUM PHARMACEUTICALS LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

Active Ingredients (in each softgel)

Simethicone 125 mg

PURPOSE

Purpose

Antigas

INDICATIONS & USAGE

Usefor the relief of pressure, bloating, fullness, commonly referred to as gas.

Warning

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 INGREDIENT

D&C Yellow 10, FD&C Blue 1, Edible Ink, Gelatin, Glycerin, Peppermint oil, POLYSORB, Purified water, Titanium dioxide.

QUESTIONS

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: 80513-117-12

Extra Strength

GAS RELIEF

Simethicone 125 mg

INGREDIENTS AND APPEARANCE

GAS RELIEF 
simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80513-117
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 (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
PEPPERMINT OIL (UNII: AV092KU4JH)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	green	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	911
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80513-117-12	120 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M002	01/01/2025

Labeler - Advanced Rx LLC (042795108)

Establishment
Name	Address	ID/FEI	Business Operations
ELYSIUM PHARMACEUTICALS LIMITED		915664486	manufacture(80513-117)