Label: ENTEX LQ- guaifenesin and phenylephrine hydrochloride liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated September 30, 2010

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  • 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

    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

  • INGREDIENTS AND APPEARANCE
    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
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