GAS-AID- simethicone tablet, chewable
Leosons Overseas Corp

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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Gas-Aid Extra strength Gas Relief Cherry Flavor

Active ingredient (in each tablet)

Simethicone 125 mg

Purpose

Anti-gas

Uses

relieves:

pressure
bloating
symptoms referred to as gas

Warnings

Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center immediately.

Directions

chew 1 to 2 tablets thoroughly as needed after meals and at bedtime
do not exceed 4 tablets in a 24 hour period except under the advice and supervision of a physician

Other information

do not use if any individual blister unit is broken or open
store at room temperature
avoid high humidity and excessive heat, above 40oC (104oF)

Inactive ingredients

D&C red 30 aluminum lake, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose

Principal Display Panel

Gas-Aid

Extra strength Gas Relief

Simethicone Anti-Gas

Cherry Flavor

Fast Relief of pressure, bloating and gas distress

18 chewable tablets

Box

GAS-AID
simethicone tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69626-7197
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 RED NO. 30 (UNII: 2S42T2808B)
DEXTROSE (UNII: IY9XDZ35W2)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SORBITOL (UNII: 506T60A25R)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	pink	Score	no score
Shape	ROUND	Size	16mm
Flavor	CHERRY	Imprint Code	G134
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69626-7197-3	2 in 1 CARTON	08/08/2015
1		9 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	08/08/2015

Labeler - Leosons Overseas Corp (148605470)

Registrant - Guardian Drug Company (119210276)

Name	Address	ID/FEI	Business Operations
Establishment
Guardian Drug Company		119210276	manufacture(69626-7197)