ENTEX T - guaifenesin and pseudoephedrine hydrochloride tablet 
WraSer Pharmaceuticals, 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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Entex Tablets

Drug Facts

Active Ingredients (in each tablet )

Guaifenesin, USP                             375 mg

Pseudoephedrine HCl, USP              60 mg

Purpose

Guaifenesin, USP                               Expectorant

Pseudoephedrine HCl, USP             Nasal decongestant

Uses

Warnings

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s Disease), or for two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this drug.

Ask a doctor before use if you have

When using this product

do not exceed the recommended dosage

Stop use and ask a doctor if

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of the reach of children.

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

Directions

Other information

Inactive Ingredients

croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate and starch.

Questions or Comments

Call weekdays from 9 AM to 4 PM CST at 1-888-252-3901 or go to http://www.wraser.com

email:medicalinfo@wraser.com

Package Label

Figure 1: 100 ct Label Rev. 10/2012

faf50d93-figure-01

ENTEX T 
guaifenesin and pseudoephedrine hydrochloride tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:66992-281
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 375 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 60 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE K30 (UNII: U725QWY32X)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL Size 18mm
Flavor Imprint Code 375
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:66992-281-10 100 in 1 BOTTLE
2 NDC:66992-281-30 30 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 09/30/2010
Labeler - WraSer Pharmaceuticals, LLC (121828334)
Establishment
Name Address ID/FEI Business Operations
Sovereign Pharmaceuticals, LLC 623168267 MANUFACTURE(66992-281)

Revised: 11/2012
Document Id: faf50d93-ff0d-464b-89e2-ff2abe2cc2fb
Set id: 1c5bff62-239b-449c-afc1-9a0e07c72bd0
Version: 3
Effective Time: 20121108
 
WraSer Pharmaceuticals, LLC