ENTEX LQ - guaifenesin and phenylephrine hydrochloride liquid
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 teaspoon (5 mL)

Guaifenesin, USP 100 mg

Phenylephrine HCl, USP 10 mg

in each 5 mL (1 teaspoonful) red, strawberry flavored liquid

Purpose

Guaifenesin, USP Expectorant

Phenylephrine 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

Age	Dose
Adults and children over 12 years of age	1 teaspoonful (5mL) every 4 hours;
Children 6 to under 12 years of age	1/2 teaspoonful (2.5 mL) every 4 hours;
Children 2 to under 6 years of age	1/4 teaspoon (1.25mL) every 4 hours
Children under 2 years of age	Ask your doctor
Do not exceed 6 doses in a 24 – hour period.

Other information

store at 20°- 25°C (68°- 77°F)

Inactive ingredients

benzoic acid USP, Bitter Masking agent, citric acid USP, D&C Red #33, edetate disodium, glycerin USP, propylene glycol USP, purified water, sodium citrate dihydrate USP, sorbitol solution and strawberry flavor.

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: 16 oz. Label Rev. 09/2010

7ca8414a-figure-01

ENTEX LQ
guaifenesin and phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:66992-280
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (GUAIFENESIN)	GUAIFENESIN	100 mg in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE)	PHENYLEPHRINE HYDROCHLORIDE	10 mg in 5 mL

Inactive Ingredients
Ingredient Name	Strength
BENZOIC ACID
ANHYDROUS CITRIC ACID
D&C RED NO. 33
EDETATE DISODIUM
GLYCERIN
PROPYLENE GLYCOL
WATER
SODIUM CITRATE
SORBITOL

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

Packaging
#	Item Code	Package Description
1	NDC:66992-280-16	473 mL in 1 BOTTLE
2	NDC:66992-280-01	10 mL 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)

Registrant - WraSer Pharmaceuticals, LLC (121828334)

Establishment
Name	Address	ID/FEI	Business Operations
Sovereign Pharmaceuticals, LLC		623168267	MANUFACTURE

Revised: 09/2010

Document Id: 7ca8414a-9c6c-4053-acd1-2d21a272bad4

Set id: 2e5e26e6-45a1-4e8b-afa2-9c1b811c52c9

Version: 1

Effective Time: 20100930

WraSer Pharmaceuticals, LLC