Label: KLERNAZ- guaifenesin, phenylephrine hydrochloride, dextromethorphan hydrobromide tablet

  • 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 August 7, 2015

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Dextromethorphan HBr 15 mg

    Guaifenesin 400 mg

    Phenylephrine HCL 10 mg

  • PURPOSE

    Purpose

    Cough Suppressant

    Expectorant

    Nasal Decongestant

  • INDICATIONS & USAGE

    Uses: temporarily relieves these symptoms occurring with a cold nasal decongestion: cough due to minor throat and bronchial irritation

    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.
  • WARNINGS

    Warnings:

    • when using this product do not exceed recommended dose.
    • 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 2 weeks after stopping MAOI drug. If you do not know if your prescription drug contains an MAOI, consult a doctor or pharmacist before taking this product.
  • STOP USE

    Stop use and ask a doctor if:

    • symptoms do not improve
    • new symptoms occur
    • redness or swelling is present
    • nervousness, dizziness or sleeplessness occur
    • symptoms do not improve within 7 days or are accompanied by fever
    • cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
  • ASK DOCTOR

    Ask a doctor before use if you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • difficulty in urination due to enlargement of the prostate gland
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema or where cough is accompanied by excessive phlegm (mucus)
  • DOSAGE & ADMINISTRATION

    Directions:

    Adults and children 12 years of age and older

    • Take 1 tablet every 4-6 hours as needed, do not exceed 4 tablets in 24 hours, or as directed by a doctor.

    Children 6-12 years:

    • Take 1/2 tablet every 4-6 hours as needed, do not exceet 2 tablets in 24 hours, or as directed by a doctor.
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding baby, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

    In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

  • INACTIVE INGREDIENT

    Colloidal Silicon Dioxide, F&C Blue # 2, Microcrystalline Cellulose, Stearic Acid

  • STORAGE AND HANDLING

    Other information:

    • Do not use if there are signs of tampering
    • Store at Controlled Room Temperature 15°-30°C (59°-86°F)
  • SPL UNCLASSIFIED SECTION

    PAC

    Pharma Associate

    Consulting, LLC

    Guntersville, AL 35976

  • Principal Display Panel - 30 Tablets Bottle Labeling

    NDC 69140-0620-03

    Klernaz

    TABLETS

    TRIPLE COMBINATION RELIEF:

    Expectorant: Guaifenesin 400MG

    Decongestant: Phenylephrine HCL 10MG

    Cough Suppressant: Dextromethorphan HBR 15MG

    30 Tablets

    Klernaz Tablets

  • INGREDIENTS AND APPEARANCE
    KLERNAZ 
    guaifenesin, phenylephrine hydrochloride, dextromethorphan hydrobromide tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69140-620
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Colorblue (Light Blue) Scoreno score
    ShapeOVALSize15mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69140-620-0330 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/07/2015
    Labeler - Pharma Associate Consultants, Inc (079418551)
    Establishment
    NameAddressID/FEIBusiness Operations
    TG United172837085manufacture(69140-620)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!