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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GAS RELIEF SIMETHICONE

Drug Facts

.

Active Ingredient

(in each chewable tablet)

Simethicone 80 mg

Purpose

Antiflatulent

Uses

relieves

Warnings

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

Keep out of reach of children

Directions

Other Information

Inactive Ingredients

dextrose, dipac sugar, maltodextrin, peppermint flavor, sorbitol, stearic acid

Questions or Comments

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

Call 804-270-4498, 8.30 am – 4.30 pm EST Monday - Friday

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
471610-607-04

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

20211105JH

PRINCIPAL DISPLAY PANEL - 80 mg

NDC 71610-607 - Simethicone 80 mg Chewable Tablets
Bottle Label 80 mg

SIMETHICONE 
simethicone tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71610-607(NDC:54738-518)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE80 mg
Inactive Ingredients
Ingredient NameStrength
DEXTROSE (UNII: IY9XDZ35W2)  
SUCROSE (UNII: C151H8M554)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
PEPPERMINT (UNII: V95R5KMY2B)  
SORBITOL (UNII: 506T60A25R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize13mm
FlavorPEPPERMINTImprint Code AP;019
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71610-607-044 in 1 BOTTLE; Type 0: Not a Combination Product10/25/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33203/01/2011
Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)
Establishment
NameAddressID/FEIBusiness Operations
Aphena Pharma Solutions - Tennessee, LLC128385585REPACK(71610-607)

Revised: 11/2021
Document Id: 24ffbc01-0a61-4225-8172-25a3ef452b57
Set id: da0cc98e-1692-405a-ab81-420d6f9df6de
Version: 2
Effective Time: 20211105
 
Aphena Pharma Solutions - Tennessee, LLC