ENTEX LQ - guaifenesin and phenylephrine hydrochloride liquid 
Physicians Total Care, Inc.

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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Entex LQ

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

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

Stop use and ask a doctor if

Do not take this product if you have

If pregnant or breast-feeding,

Keep out of reach of children

Directions

AgeDose
Adults and children over 12 years of age1 teaspoonful (5mL) every 4 hours;
Children 6 to under 12 years of age1/2 teaspoonful (2.5 mL) every 4 hours;
Children 2 to under 6 years of age1/4 teaspoon (1.25mL) every 4 hours
Children under 2 years of ageAsk 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

image of 473 mL package label

ENTEX LQ 
guaifenesin and phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-6241(NDC:66992-280)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorredScore    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54868-6241-0473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/01/2011
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIBusiness Operations
Physicians Total Care, Inc.194123980relabel

Revised: 9/2010
Document Id: 67e1dbc2-7747-4971-8916-e0bca4f7293f
Set id: 0accdd47-9712-4faa-aae4-ad1e641b26a1
Version: 1
Effective Time: 20100930
 
Physicians Total Care, Inc.