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Simethicone by Aphena Pharma Solutions - Tennessee, LLC

Medically reviewed on Feb 6, 2018

Dosage form: tablet, chewable
Ingredients: SIMETHICONE 80mg
Labeler: Aphena Pharma Solutions - Tennessee, LLC
NDC Code: 67544-767

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.

MY TAB FOR GAS SIMETHICONE 80 MG

Drug Facts

.

Active Ingredient

(in each chewable tablet)

Simethicone 80 mg

Purpose

Antiflatulent

Uses

relieves

  • bloating
  • pressure
  • discomfort of gas which can be caused by certain foods or air swallowing

Warnings

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

Keep out of reach of children

Directions
  • chew thoroughly 1 to 2 tablets as needed after meals and at bed time.
  • do not exceed 6 tablets per day unless directed by a physician

Other Information
  • store at room temperature 15-30 °C (59-86 °F)
  • protect from moisture

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 OR BAND AROUND ANY CAPSULE IS MISSING OR DAMAGED

Distributed by: Qualitest Pharmaceuticals, Inc.

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
467544-767-04

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:

Cookeville, TN 38506

20171222DKJ

PRINCIPAL DISPLAY PANEL - 80mg

NDC 67544-767 Simethicone (MTAB) 80mg - Rx Only

SIMETHICONE 
simethicone tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67544-767(NDC:0603-0210)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SIMETHICONE (SIMETHICONE) SIMETHICONE80 mg
Inactive Ingredients
Ingredient NameStrength
DEXTROSE 
SUCROSE 
MALTODEXTRIN 
PEPPERMINT 
SORBITOL 
STEARIC ACID 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize13mm
FlavorPEPPERMINTImprint CodeAP;019
Contains    
Packaging
#Item CodePackage Description
1NDC:67544-767-044 TABLET, CHEWABLE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33203/12/1999
Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)
Establishment
NameAddressID/FEIOperations
Aphena Pharma Solutions - Tennessee, LLC128385585REPACK(67544-767)

 
Aphena Pharma Solutions - Tennessee, LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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