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 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

Age	Dose
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

ENTEX PAC
guaifenesin, pseudoephedrine hydrochloride, dextromethorphan hydrobromide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:66992-285

Packaging
#	Item Code	Package Description
1	NDC:66992-285-34	1 in 1 PACKAGE, COMBINATION

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	30
Part 2	1 BOTTLE	118 mL

Part 1 of 2

ENTEX T
guaifenesin and pseudoephedrine hydrochloride tablet

Product Information
Item Code (Source)	NDC:66992-281
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (GUAIFENESIN)	GUAIFENESIN	375 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE)	PSEUDOEPHEDRINE HYDROCHLORIDE	60 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	OVAL	Size	18mm
Flavor		Imprint Code	375
Contains

Packaging
#	Item Code	Package Description
1	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

Part 2 of 2

ENTEX S
dextromethorphan hydrobromide liquid

Product Information
Item Code (Source)	NDC:66992-290
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg in 5 mL

Inactive Ingredients
Ingredient Name	Strength
BENZOIC ACID
EDETATE DISODIUM
FD&C RED NO. 40
PROPYLENE GLYCOL
WATER
SACCHARIN SODIUM
SORBITOL

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description
1	NDC:66992-290-04	118 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/30/2011	08/31/2013

Labeler - WraSer Pharmaceuticals, LLC (121828334)

Establishment
Name	Address	ID/FEI	Business Operations
Sovereign Pharmaceuticals, LLC		623168267	MANUFACTURE(66992-285)

Revised: 12/2012

Document Id: 5f035556-1e9d-46c2-be6d-1a97c429769c

Set id: b716017c-c1a3-4e06-a434-5443c489e23f

Version: 2

Effective Time: 20121213

WraSer Pharmaceuticals, LLC