GAS RELIEF- simethicone tablet, chewable

Gas Relief by

Drug Labeling and Warnings

Gas Relief by is a Otc medication manufactured, distributed, or labeled by Northeast Pharma, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each chewable tablet)

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

• do not take more than directed
• chew or crush tablets completely before swallowing; do not swallow tablets whole
• adults and children 12 years and over: take 1 or 2 chewable tablets as needed after meals and at bedtime
• do not exceed 4 chewable tablets in 24 hours unless directed by a doctor
• children under 12 years: ask a doctor

Other information

• each tablet contains: calcium 85 mg
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• protect from moisture
• use by expiration date on package

Inactive ingredients

crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, FD&C red #40 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide, starch, sucralose, tribasic calcium phosphate

Questions or comments?

1-800-383-0648

Principal display panel

Heartland®
Pharma Co.

NDC: 80136-859-68

Extra Strength
GAS RELIEF
Simethicone 125 mg Chewable Tablets
Antigas

Relieves
Pressure
Bloating
Discomfort

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

Chew or crush tablets completely before swallowing.

100 Chewable Tablets

Actual
Size

TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by Haleon CH SARL, owner of the registered trademark
Gas-X® Extra Strength.

50844           REV1220A60812

Distributed by:
NORTHEAST PHARMA
Williston, VT 05495
www.heartlandpharmaco.com
1-800-383-0648

44-608

INGREDIENTS AND APPEARANCE

GAS RELIEF 
simethicone tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80136-859
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
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
D&C RED NO. 30 ALUMINUM LAKE (UNII: GE75M6YV5W)
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)
FD&C RED NO. 40 ALUMINUM LAKE (UNII: 6T47AS764T)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
DIMETHICONE 410 (UNII: TYU5GP6XGE)

Product Characteristics
Color	pink	Score	no score
Shape	ROUND	Size	14mm
Flavor	CHERRY	Imprint Code	44;608
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80136-859-68	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/30/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M002	06/30/2023

Labeler - Heartland Pharma Co. (119127089)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	manufacture(80136-859) , pack(80136-859)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		117025878	manufacture(80136-859)