Label: ZYNCOF- dextromethorphan hbr and guaifenesin syrup

  • NDC Code(s): 52083-400-01, 52083-400-04, 52083-400-16
  • Packager: Kramer Novis
  • 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 July 2, 2015

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

  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-400
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    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    
    ShapeSize
    FlavorGRAPE (GRAPE) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52083-400-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2011
    2NDC:52083-400-04120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2011
    3NDC:52083-400-16474 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/23/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/01/2011
    Labeler - Kramer Novis (090158395)