SIMETHICONE- simethicone tablet, chewable 
Aphena Pharma Solutions - Tennessee, LLC

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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gc 791

Active ingredient (in each tablet)

Simethicone 80 mg

Purpose

Anti-Gas

Uses

relieves pressure, bloating, and fullness
commonly referred to as gas

Warnings

If pregnant or breast feeding, ask a health professional before use.

Keep out of reach of children.

Directions

Do not exceed 6 tablets in 24 hours except under the advice and supervision of a doctor.

Other information

HOW SUPPLIED

Simethicone Chewable Tablets, 80 mg are white, round, tablets, debossed with "44 & 137" on one side and are supplied as:

NDC 57896-791-01 in bottle of 100 chewable tablets

NDC 57896-791-08 in bottle of 80 chewable tablets

Distributed by:

GERI-CARE Pharmaceuticals Corp.

1650 63rd Street, Brooklyn, NY 11204

Inactive ingredients

cellulose, corn starch, crospovidone, dextrates hydrated, flavor,
magnesium stearate, silica, sucralose, calcium phosphate.

Questions or comments?

1-800-540-3765

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count80 mg
471610-649-04

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:
Aphena Pharma Solutions - TN
Cookeville, TN 38506

20220519JK

PRINCIPAL DISPLAY PANEL - 80 mg

NDC 71610-649 - Simethicone 80 mg Chewable Tablet - Rx Only
Bottle Label 80 mg

SIMETHICONE 
simethicone tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71610-649(NDC:57896-791)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE80 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
DEXTRATES (UNII: G263MI44RU)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
STARCH, CORN (UNII: O8232NY3SJ)  
CROSPOVIDONE (UNII: 2S7830E561)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize13mm
FlavorPEPPERMINTImprint Code 44;137
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71610-649-044 in 1 BOTTLE; Type 0: Not a Combination Product05/19/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33201/01/2004
Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)
Establishment
NameAddressID/FEIBusiness Operations
Aphena Pharma Solutions - Tennessee, LLC128385585REPACK(71610-649)

Revised: 6/2022
Document Id: b90721af-b67e-4a2e-b05c-a679f5842c0e
Set id: 5df94be7-0bc9-4be1-9982-8193e3a3c8ef
Version: 2
Effective Time: 20220617
 
Aphena Pharma Solutions - Tennessee, LLC