Entex PAC

Dosage form: kit
Ingredients: GUAIFENESIN 375mg, PSEUDOEPHEDRINE HYDROCHLORIDE 60mg; DEXTROMETHORPHAN HYDROBROMIDE 20mg in 5mL
Labeler: WraSer Pharmaceuticals, LLC
NDC Code: 66992-285

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.

Entex PAC

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 the 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Figure 1: Entex PAC carton

ENTEX PAC 
guaifenesin, pseudoephedrine hydrochloride, dextromethorphan hydrobromide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66992-285
Packaging
#Item CodePackage Description
1NDC:66992-285-341 KIT (KIT) in 1 PACKAGE, COMBINATION
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 Code375
Contains    
Packaging
#Item CodePackage Description
1NDC:66992-281-3030 TABLET (TABLET) in 1 BOTTLE
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 Description
1NDC:66992-290-04118 mL in 1 BOTTLE
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 finalpart34108/30/201108/31/2013
Labeler - WraSer Pharmaceuticals, LLC (121828334)
Establishment
NameAddressID/FEIOperations
Sovereign Pharmaceuticals, LLC623168267MANUFACTURE(66992-285)

Revised: 12/2012
 
WraSer Pharmaceuticals, LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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