GAS RELIEF- simethicone tablet, chewable 
Northeast Pharma

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Heartland Pharma 44-608

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

Other information

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 GSK Consumer
Healthcare S.A., owner of the registered trademark Gas-X® Extra Strength.
50844            ORG122060812

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

Heartland Pharma 44-608

Heartland Pharma 44-608

GAS RELIEF 
simethicone tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80136-859
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
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
ColorpinkScoreno score
ShapeROUNDSize14mm
FlavorCHERRYImprint Code 44;680
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80136-859-68100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/30/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00206/30/2023
Labeler - Northeast Pharma (081232935)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837manufacture(80136-859) , pack(80136-859)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.117025878manufacture(80136-859)

Revised: 6/2023
Document Id: b6f991e1-0121-487b-9db7-a10342c3cee8
Set id: 0860114c-53ec-48bd-a2f2-0b0bf8d2db6e
Version: 2
Effective Time: 20230630
 
Northeast Pharma