EXTRA STRENGTH GAS RELIEF - silicon dioxide capsule, liquid filled
P and L Development of New York Corporation

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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Active Ingredient (in each softgel)

Simethicone 125mg

Purpose

Antiflatulent (Antigas)

Use

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

Warnings

Stop using this product and ask a doctor if condition persists. If pregnant or breastfeeding, 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

swallow 1 or 2 softgels as needed after meals and at bedtime
do not exceed 4 softgelsin 24 hours except under the advice and supervision of a physician.

Other information

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

Inactive Ingredients

DandC Yellow #10, edible ink, FDandC Blue #1, FDandC Red #40, gelatin, glycerin, peppermint oil, purified water, sorbitol special, and titanium dioxide

Questions or comments?

call toll free: 1-877-753-3935

Distributed by:
PL Developments
Westbury, NY 11590, USA

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

NDC 59726-550-30

*Compare to the active ingredient in Extra Strength Gas-X (R)

Extra Strength

Gas Relief

Simethicone, 125mg

Antigas

Relieves Bloating, Pressure, Fullness and Gas

30softgels

Product Packaging

Extra Strength Gas Relief

EXTRA STRENGTH GAS RELIEF
simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59726-550(NDC:10888-4800)
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SILICON DIOXIDE (D&C YELLOW NO. 10)	SILICON DIOXIDE	125 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN
GLYCERIN
PEPPERMINT OIL
WATER
SORBITOL
TITANIUM DIOXIDE

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

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:59726-550-30	1 BLISTER PACK ( BLISTER PACK) in 1 BOX	contains a BLISTER PACK
1		30 CAPSULE, LIQUID FILLED ( CAPSULE) in 1 BLISTER PACK	This package is contained within the BOX (59726-550-30)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part332	09/01/2011

Labeler - P and L Development of New York Corporation (800014821)

Revised: 09/2011 P and L Development of New York Corporation