ENTEX PAC  - guaifenesin, pseudoephedrine hydrochloride, dextromethorphan hydrobromide   
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

Active ingredients for each Entex-T tablet:

Guaifenesin, USP 375 mg

Pseudoephedrine HCl, USP 60 mg

Active ingredients for each 5 mL (1 teaspoonful) Entex-S liquid:

Dextromethorphan HBr, USP   20 mg

Purpose

Guaifenesin, USP Expectorant

Pseudoephedrine HCl, USP Nasal decongestant

Dextromethorphan HBr, USP Antitussive

Uses

Use for Entex-T tablet:

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
Use for Entex-S liquid:
Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

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).
a cough that occurs with too much 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. These could be signs of a serious condition.

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

Directions for use, Entex-T tablets:
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

Directions for use, Entex-S liquid:

do not take more than 4 doses in any 24-hour period
AgeDose
Adults and children 12 years of age and over:1 teaspoon every 4 hours
Children 6 to under 12 years of age:1/2 teaspoon every 4 hours

Other information

store at 20°- 25°C (68°- 77°F)

Inactive ingredients

Inactive ingredients for Entex-T tablet:

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

Inactive ingredients for Entex-S liquid:

Benzoic acid, editate disodium, FD&C Red #40, propylene glycol, purified water, saccharin sodium, sorbitol solution and strawberry flavoring

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: Entex PAC carton

94e77e8f-figure-01

ENTEX PAC 
guaifenesin, pseudoephedrine hydrochloride, dextromethorphan hydrobromide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66992-285
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:66992-285-341 KIT ( KIT) in 1 PACKAGE, COMBINATIONNone
QUANTITY OF PARTS
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE   30 
Part 21 BOTTLE   118 mL
Part 1 of 2
ENTEX T 
guaifenesin and pseudoephedrine hydrochloride tablet
Product Information
Item 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
166992-281-3030 TABLET ( TABLET) in 1 BOTTLENone
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart341

Part 2 of 2
ENTEX S 
dextromethorphan hydrobromide liquid
Product Information
Item Code (Source)NDC:66992-290
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID 
EDETATE DISODIUM 
FD&C RED NO. 40 
PROPYLENE GLYCOL 
WATER 
SACCHARIN SODIUM 
SORBITOL 
Product Characteristics
ColorREDScore    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
166992-290-04118 mL in 1 BOTTLENone
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart341


Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/30/2011

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

Revised: 09/2011 WraSer Pharmaceuticals, LLC