ANTIGAS EXTRA STRENGTH- simethicone capsule, liquid filled
Western Family Foods, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DRUG FACTS

Active Ingredient (in each softgel)

Simethicone 125 mg

Purpose

Antiflatulent

Uses

for relief of:
- bloating
- pressure
- fullness
- stuffed feeling commonly referred to as gas.

Warnings

Stop using this product 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 or at bedtime. Do not exceed 4 softgels per day, unless directed by a doctor.

Other information

store at controlled room temperature 15°-30°C (59°-86°F)
protect from heat and moisture
*This product is not manufactured or distributed by Novartis Consumer Health Inc., owner of the registered trademark Extra Strength Gas- X®

Inactive Ingredients

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

Questions or comments?

call toll free 1-877-753-3935

Principal Display Panel

Compare to the active ingredient in Extra Strength Gas-X®*

AntiGas

Extra Strength

Simethicone, 125mg

Fast relief of:

bloating, pressure, fullness and gas

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

Proudly Distributed by:

Western Family Foods, Inc.

PO Box 4057, Portland, OR 97208 USA

www.westernfamily.com

Product Label

Simethicone 125 mg

ANTIGAS EXTRA STRENGTH
simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55312-550
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	125 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55312-550-30	2 in 1 CARTON	03/13/2010	12/31/2018
1		15 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:55312-550-50	5 in 1 CARTON	03/13/2010	12/31/2018
2		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part332	03/13/2010	12/31/2018

Labeler - Western Family Foods, Inc. (192166072)

Revised: 12/2018

Document Id: 3bc9b1d2-eb53-4699-9a6c-7c3312959e4f

Set id: a1f0399b-1c37-4e54-a114-80c345e886ec

Version: 3

Effective Time: 20181228

Western Family Foods, Inc.