MUCUS RELIEF- guaifenesin 200 mg 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 Caplets, 200 mg

Active ingredient (in each tablet)

Guaifenesin 200 mg

Purpose

Expectorant

Uses

Warnings

ask a doctor before use if you have

KEEP OUT OF REACH OF CHILDREN 

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

IN CASE OF PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

stop use and ask a doctor

if cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache.These could be signs of serious illness

Directions:

OTHER  INFORMATION

Inactive ingredients

colloidal silicon dioxide, FD&C RED#40(Al-lake), magnesium stearate, maltodextrin,  microcrystalline cellulose, stearic acid, sodium starch glycolate

Questions or Comments

call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

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
300071610-098-18

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

20180718JH

PRINCIPAL DISPLAY PANEL - 200 mg

NDC 71610-098 - Guaifenesin 200 mg - Rx Only
Bottle Label 200 mg

MUCUS RELIEF 
guaifenesin 200 mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71610-098(NDC:54738-980)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
POVIDONE (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorredScore2 pieces
ShapeROUNDSize10mm
FlavorImprint Code AP;151
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71610-098-183000 in 1 BOTTLE; Type 0: Not a Combination Product07/16/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/01/2016
Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)
Establishment
NameAddressID/FEIBusiness Operations
Aphena Pharma Solutions - Tennessee, LLC128385585REPACK(71610-098)

Revised: 7/2018
Document Id: 34de35ef-20f0-4707-9f11-dcf8c4040796
Set id: 2ae3c1e1-2a12-444d-a763-590320d373e1
Version: 2
Effective Time: 20180718
 
Aphena Pharma Solutions - Tennessee, LLC