GAS RELIEF ULTIMATE STRENGTH SOFTGELS- 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, Ocean Healthcare Pvt Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each softgel)

Simethicone 500 mg

Purpose

Antigas

Use

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

Warning

Stop use and ask a doctor if

condition persists.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of chindren.

Directions

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

Other information

• store at 20º to 25ºC (68º to 77ºF)
• protect from light, heat and moisture

Inactive ingredients

Gelatin, glycerin, purified water, sorbitol.

Questions?

call 1-800-630-8895

Principal Display Panel

INGREDIENTS AND APPEARANCE

GAS RELIEF   ULTIMATE STRENGTH SOFTGELS
simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80513-119
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE, UNSPECIFIED	500 mg

Inactive Ingredients
Ingredient Name	Strength
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	white (white (natural color))	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	OS
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80513-119-50	50 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2026
2	NDC: 80513-119-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M002	02/01/2026

Labeler - Advanced Rx LLC (042795108)

Registrant - Advanced Rx LLC (042795108)

Establishment
Name	Address	ID/FEI	Business Operations
Ocean Healthcare Pvt Ltd		873673519	manufacture(80513-119)