GAS RELIEF EXTRA STRENGTH- simethicone capsule, liquid filled

Gas Relief by

Drug Labeling and Warnings

Gas Relief by is a Otc medication manufactured, distributed, or labeled by EQUATE (Wal-Mart Stores, Inc.), P & L Development, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active Ingredient (in each softgel)

Simethicone 125 mg

Purpose

Antiflatulent (Antigas)

Use

• relieves bloating, pressure, or fullness commonly referred to as gas.

Warnings

Stop use and ask a doctor if

condition persists

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 4 softgels in 24 hours except under the advice and supervision of a physician.

Other information

• store at controlled room temperature 15°-30°C (59°-86°F)
• protect from heat and moisture

Inactive Ingredients

D&C Yellow #10, edible ink, FD&C Blue #1, FD&C Red #40, gelatin, glycerin, peppermint oil, purified water, sorbitol special and titanium dioxide.

Questions or comments?

1-888-287-1915

Principal Display Panel

Compare to Extra Strength Gas-X® active ingredient*

Extra Strength

Gas Relief

Anti-Gas/ Simethicone

Relieves:

• Pressure
• Bloating
• Discomfort

EACH DOSE IS INDIVIDUALLY SEALED IN A BLISTER PACK.

DO NOT USE IF BLISTER UNIT IS TORN OR BROKEN.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Extra Strength Gas-X®.

Product Label

Simethicone 125 mg

INGREDIENTS AND APPEARANCE

GAS RELIEF  EXTRA STRENGTH
simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-550
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)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
PEPPERMINT OIL (UNII: AV092KU4JH)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	GREEN	Score	no score
Shape	OVAL	Size	9mm
Flavor		Imprint Code	PO
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-550-72	4 in 1 CARTON	07/06/2010	12/31/2020
1		18 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 49035-550-60	4 in 1 CARTON	07/06/2010	12/31/2020
2		15 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 49035-550-20	2 in 1 CARTON	07/06/2010	12/31/2020
3		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC: 49035-550-14	2 in 1 PACKAGE	07/06/2010	12/31/2020
4		72 in 1 BOTTLE; 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	07/06/2010	12/31/2020

Labeler - EQUATE (Wal-Mart Stores, Inc.) (051957769)

Registrant - P & L Development, LLC (800014821)