ZYNCOF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) TABLET [KRAMER NOVIS]

ZYNCOF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) TABLET [KRAMER NOVIS]
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NDC 52083-410-02
Set ID 72f4ae9a-a31f-4cb8-8162-dafdb01912b1
Category HUMAN OTC DRUG LABEL
Packager KRAMER NOVIS
Generic Name
Product Class
Product Number
Application Number PART341
  • Drug Facts

  • Active Ingredients (in each immediate-release tablet)

    Dextromethorphan HBr, 20 mg

    Guaifenesin, 400 mg

  • Purpose

    Cough Suppressant

    Expectorant

  • 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.

  • INDICATIONS & USAGE

    Uses • helps loosen phlegm (mucus) • helps thin bronchial secretions to make coughs more productive • temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold

  • WARNINGS

    WarningsDo 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 2 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 product.

    Ask a doctor before use if you have • cough accompanied by excessive phlegm (mucus) • persistent chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

    When using this product do not exceed recommended dose • do not use for more than 7 days

    Stop use and ask a doctor if • cough lasts more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

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

  • DOSAGE & ADMINISTRATION

    Directions • Adults and children 12 years of age and older: take 1 tablet every 4 hours with a glass full of water while symptoms persist. Do not exceed 6 doses in 24 hours • Children under 12 years of age: do not use

  • INACTIVE INGREDIENT

    Inactive ingredients • colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate, stearic acid.

  • STORAGE AND HANDLING

    Other information • Tamper evident: Do not use if packet is torn, cut or opened • Store at 25°C (77°F) excursions permitted between 15-30ºC (59-86°F) • keep in a dry place and do not expose to excessive heat

  • SPL UNCLASSIFIED SECTION

    Manufactured in the USA for Kramer Novis. San Juan, PR 00917.

    T: (787) 767-2072 / www.kramernovis.com

  • Packaging

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  • INGREDIENTS AND APPEARANCE
    ZYNCOF 
    dextromethorphan hydrobromide, guaifenesin tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-410
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONES (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeOVALSize17mm
    FlavorImprint Code TCL280
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52083-410-022 in 1 PACKET; Type 0: Not a Combination Product06/26/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/26/2015
    Labeler - KRAMER NOVIS (090158395)

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