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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Drug Facts

Active Ingredients (per tablet)

Guaifenesin, USP                             375 mg

Pseudoephedrine HCl, USP              60 mg

Purpose

Guaifenesin, USP                               Expectorant

Pseudoephedrine HCl, USP             Nasal decongestant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
for the temporary relief of nasal and sinus congestion due to cold, hay fever or other respiratory allergies

WARNINGS

Do not exceed recommended dosage.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

a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema or where cough is accompanied by excessive phlegm (mucus).

Stop use and ask a doctor if

nervousness, dizziness, or sleeplessness occur.
symptoms do not improve within 7 days or are accompanied by fever.
a cough persists for more than 1 week or is accompanied by a fever, rash or persistent headache.

Do not take this product if you have

heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to enlarged prostate gland
breathing problems such as emphysema or chronic bronchitis.

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 immediately.

Directions

Take every 4 to 6 hours
do not exceed 4 doses in 24 hours
Adults and children 12 years of age and over: 1 tablet
Children 6 to under 12 years of age: 1/2 tablet

Other information

store at 20°- 25°C (68°- 77°F)

Inactive ingredients

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

Questions or Comments?

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

email:medicalinfo@wraser.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Figure 1: 100 ct Label Rev. 03/2011

80a9992d-figure-01


ENTEX T 
guaifenesin and pseudoephedrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66992-281
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN375 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE60 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE K30 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STARCH, CORN 
Product Characteristics
ColorWHITEScore2 pieces
ShapeOVALSize18mm
FlavorImprint Code 375
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:66992-281-10100 TABLET ( TABLET) in 1 BOTTLENone
2NDC:66992-281-3030 TABLET ( TABLET) in 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/30/2010

Labeler - WraSer Pharmaceuticals, LLC (121828334)
Establishment
NameAddressID/FEIOperations
Sovereign Pharmaceuticals, LLC623168267MANUFACTURE

Revised: 09/2010 WraSer Pharmaceuticals, LLC