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ZYNCOF (Kramer Novis)

Available Formats

Dosage Form Package Information Links
SYRUP 120 mL in 1 BOTTLE, PLASTIC (52083-400-04) Label Information
SYRUP 400 mL in 1 BOTTLE, PLASTIC (52083-400-16) Label Information

Complete ZYNCOF Information

  • Active ingredients (in each 5 mL tsp)

    Dextromethorphan HBr, USP 20 mg

    Guaifenesin, USP 400 mg


  • Purpose

    Cough suppressant

    Expectorant


  • Uses

    • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

  • Warnings

    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 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 that occurs with too much phlegm (mucus)
    • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    When using this product do not use more than directed.
  • STOP USE

    Stop use and ask a doctor if cough lasts more than 7 days, comes back or is accompanied by fever, rash, or persistent headache.

    These could be signs of a serious condition.


  • PREGNANCY OR BREAST FEEDING

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


  • Keep out of reach of children.

    In case of accidental overdose, get medical help or contact a Poison Control Center right away.


  • Directions

    • do not take more than 6 doses in any 24-hour period
    • EVERY 4 HOURS
    • Adults and Children 12 years of age and over 5 mL (1 tsp)
    • Children under 12 years of age consult physician

  • Other information

    • Tamper evident feature: Do not use if inner seal is torn, broken or missing.
    • Store at controlled room temperature 15°-30°C (59° to 86°F).
    • Avoid excessive heat or humidity.

  • Inactive ingredients

    Citric acid, eucalyptus oil, flavors, menthol, methyl paraben, polyethylene glycol, propylene glycol, propyl paraben, purified water, sodium citrate and sucralose.


  • SPL UNCLASSIFIED SECTION

    Made in the USA for Kramer Novis.

    San Juan, PR 00917

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


  • PRINCIPAL DISPLAY PANEL

    Q-Tussin DM 10mg/100mg


  • INGREDIENTS AND APPEARANCE
    ZYNCOF 
    dextromethorphan hbr and guaifenesin syrup
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:52083-400
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor GRAPE (GRAPE) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52083-400-01 30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2011
    2 NDC:52083-400-04 120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2011
    3 NDC:52083-400-16 474 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/23/2013
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 06/01/2011
    Labeler - Kramer Novis (090158395)