GUAIFENESIN 200MG- guaifenesin tablet 
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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Guaifenesin 200mg

GUAIFENESIN 200 MG TABLETS

Marlex Pharmaceuticals, Inc.

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Drug Fact

Active ingredient (in each tablet)

Guaifenesin 200mg

Purpose

Expectorant

Guaifenesin 200 mg Tablets

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageway of bothersome mucus and make coughs more productive

Warnings

Ask a doctor before use if you have

Stop use and ask a doctor if

cough last more than 7 days, come back or is accompanied by fever, rash, or persistent headache. There could be signs of a serious illness. 

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

 

If pregnant or breast- feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions:

Other Information:

Inactive Ingredients:

Colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, stearic acid

Manufactured for & Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

Rev: 02/19TCL

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:

Count200 mg
300071610-434-18

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

20200619JH

PRINCIPAL DISPLAY PANEL - 200 mg

NDC 71610-434 - Guaifenesin 200 mg Tablets
Bottle Label 200 mg

GUAIFENESIN 200MG 
guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71610-434(NDC:10135-681)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize8mm
FlavorImprint Code G2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71610-434-183000 in 1 BOTTLE; Type 0: Not a Combination Product06/16/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/01/2019
Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)
Establishment
NameAddressID/FEIBusiness Operations
Aphena Pharma Solutions - Tennessee, LLC128385585REPACK(71610-434)

Revised: 6/2020
Document Id: 5dd755ce-6ef4-4341-a8e9-cd7d342442ea
Set id: 45ac210a-8c54-4469-8e10-e6fe52b89cb5
Version: 1
Effective Time: 20200619
 
Aphena Pharma Solutions - Tennessee, LLC