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 250 mg

Purpose

Antigas

Use

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

Warnings

ASK DOCTOR

Stop use and ask a doctor if condition persists

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 and children 12 years and older:swallow with water 1 or 2 softgels as needed after meals and at bedtime
• do not exceed 2 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

D&C red #33, FD&C blue #1, gelatin, glycerin, purified water and white edible ink.

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: 80513-112-01

Compare to the active ingredient in Maximum Strength Gas-X ®†

HIGH POTENCY

GAS RELIEF

Simethicone 250 mg

RELIEVES GAS FAST

PRESSURE

BLOATING

DISCOMFORT

100 SOFTGELS

†This product is not manufactured or distributed by the owner of the registered trademark Maximum Strength Gas-X ®

INGREDIENTS AND APPEARANCE

GAS RELIEF 
simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80513-112
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	250 mg

Inactive Ingredients
Ingredient Name	Strength
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	purple (Transparent Purple)	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	PC31
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80513-112-01	100 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)