ENTEX LQ- guaifenesin and phenylephrine hydrochloride liquid

ENTEX LQ by

Drug Labeling and Warnings

ENTEX LQ by is a Otc medication manufactured, distributed, or labeled by Physicians Total Care, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

ENTEX LQ (guaifenesin and phenylephrine hydrochloride) liquid

473 mL (5 mL per teaspoon)

NDC: 54868-6241-0

INGREDIENTS AND APPEARANCE

ENTEX LQ 
guaifenesin and phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54868-6241(NDC: 66992-280)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
BENZOIC ACID (UNII: 8SKN0B0MIM)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54868-6241-0	473 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	04/01/2011

Labeler - Physicians Total Care, Inc. (194123980)

Establishment
Name	Address	ID/FEI	Business Operations
Physicians Total Care, Inc.		194123980	relabel