KLERNAZ (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) TABLET [PHARMA ASSOCIATE CONSULTANTS, INC]

KLERNAZ (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) TABLET [PHARMA ASSOCIATE CONSULTANTS, INC]
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NDC 69140-620-03
Set ID 1cba7bae-bc4b-2fc5-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Pharma Associate Consultants, Inc
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • 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)

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