Gas Relief (Simethicone) Capsule, Liquid Filled [Puracap Pharmaceutical Llc] -

GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC]
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Drug Facts
Active ingredient (in each softgel)

Simethicone 125 mg
Purpose

Antigas
Uses
for the relief of
- pressure, bloating, and fullness commonly referred to as gas
Warnings

Keep out of reach of children.
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 room temperature 15°-30°C (59°-86°F)
- protect from light, heat and moisture
Inactive ingredients

D&C yellow #10, FD&C blue #1, FD&C red #40, gelatin, glycerin, peppermint oil, purified water, white edible ink
Questions or comments?

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PRINCIPAL DISPLAY PANEL

EXTRA STRENGTH GAS RELIEF

SIMETHICONE 125 mg ANTI-GAS 20 Softgels

NDC 51013-430-08

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

INGREDIENTS AND APPEARANCE

GAS RELIEF
simethicone capsule, liquid filled

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:51013-430-08	2 in 1 CARTON	03/27/2018
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:51013-430-09	5 in 1 CARTON	03/27/2018
2		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:51013-430-07	4 in 1 CARTON	03/27/2018
3		18 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	03/27/2018

Labeler - PURACAP PHARMACEUTICAL LLC (962106329)

Name	Address	ID/FEI	Business Operations
Establishment
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.		421293287	manufacture(51013-430) , analysis(51013-430)

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