GAS RELIEF- simethicone 180 mg capsule, liquid filled

Gas Relief by

Drug Labeling and Warnings

Gas Relief by is a Otc medication manufactured, distributed, or labeled by We Care Distributor Inc., SOFTGEL HEALTHCARE PVT LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each softgel)                                         Purpose

Simethicone 180 mg............................................................. Antigas

Uses

for relief of

■ pressure, bloating, and fullness commonly referred to as gas

Warnings

If pregnant or breast-feeding,

ask a health care professional before use

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

■ adults: 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 controlled room temperature 20°-25°C (68°-77°F).

■ protect from moisture

■ read all product information before using.

■ keep this box for important information

Inactive ingredients

FD&C yellow 6, gelatin, glycerin, hypromellose, peppermint oil, purified water, sorbitol, titanium dioxide

Questions or comments?

1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com

PRINCIPAL DISPLAY PANEL

Compare to the Active Ingredients in
Gas-X Ultra Strength

Simethicone Softgels, 80 mg

TO OPEN
PUSH IN TAB AND PULL OUT

25 Pouches of 2 Softgel Each

INGREDIENTS AND APPEARANCE

GAS RELIEF 
simethicone 180 mg capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70005-019
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	180 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
HYPROMELLOSES (UNII: 3NXW29V3WO)
PEPPERMINT OIL (UNII: AV092KU4JH)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	orange	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	P10
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70005-019-25	25 in 1 BOX
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 70005-019-50	50 in 1 BOX
2		2 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 70005-019-02	2 in 1 POUCH
3		2 in 1 POUCH; 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	10/01/2009

Labeler - We Care Distributor Inc. (079832998)

Establishment
Name	Address	ID/FEI	Business Operations
SOFTGEL HEALTHCARE PVT LTD		675584180	manufacture(70005-019)