MEDIQUE GUAICON DMS (GUAIFENESIN, DEXTROMETHORPHAN HBR) SYRUP [UNIFIRST FIRST AID CORPORATION]

MEDIQUE GUAICON DMS (GUAIFENESIN, DEXTROMETHORPHAN HBR) SYRUP [UNIFIRST FIRST AID CORPORATION]
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NDC 47682-217-71
Set ID 21ade7e3-3b17-4ed4-bbbd-28efef68254b
Category HUMAN OTC DRUG LABEL
Packager UNIFIRST FIRST AID CORPORATION
Generic Name
Product Class
Product Number
Application Number PART341
  • Drug Facts

  • Active ingredients

    Guaifenesin 100 mg, Dextromethorphan Hydrobromide 10 mg

  • Purpose

    Expectorant/Cough suppressant

  • INDICATIONS & USAGE

    Uses

    Temporarily

    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus, drain bronchial tubes, and make coughs more productive
    • suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants

  • WARNINGS

    Warnings

  • DO NOT USE

    Do not use

    • more than the 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 using this product

  • STOP USE

    Stop use and ask a doctor if

    • new symptoms occur
    • cough lasts more than 7 days, comes back, or is accompanied by a fever, rash, or persistent headache.

    These are signs of a serious condition.


  • ASK DOCTOR

    Ask a doctor before use if you have a

    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • cough accompanied by excessive phlegm (mucus)

  • PREGNANCY OR BREAST FEEDING

    If preganant or breast feeding, 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 for children even if you do not notice any signs or symptoms.

  • Directions

    Adults and children (12 years of age and older)

    Take 2 teaspoons (10 ml) every 4 hours as needed, do not exceed 12 teaspoons (6 doses) in 24 hours, or as directed by a doctor.

    Children under 12 years of age

    Do not give to children under 12 years of age.

  • OTHER SAFETY INFORMATION

    Other information

    • tamper evident, do not use if container is torn, cut or opened
    • store at controlled room temperature 15°-30°C (59°-86°F)
    • avoid excessive heat and humidity
  • Inactive ingredients

    citric acid, FD&C red 40, flavor, glycerin, methylparaben, propylene glycol,

    propylparaben, purified water, sodium citrate, sucralose

  • Questions or comments

    Call 1-800-634-7680

  • PRINCIPAL DISPLAY PANEL

    Medique®

    Guaicon DMS

    InstyDose®

    Sugar-Free/Alcohol Free

    Liquid Cough Relief

    Expectorant • Guaifenesin 200 mg

    Cough Suppressant • Dextromethorphan HBr 20 mg

    20 - 10 ml

    Liquid

    Packets

    Tamper evident Unit Dose Packets

    217R Guaicon DMS InstyDose Label

  • INGREDIENTS AND APPEARANCE
    MEDIQUE GUAICON DMS 
    guaifenesin, dextromethorphan hbr syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-217
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorred (CHERRY RED) Score    
    ShapeSize
    FlavorCHERRY (SOUR CHERRY) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-217-7120 in 1 BOX04/05/2011
    110 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/05/2011
    Labeler - UNIFIRST FIRST AID CORPORATION (832947092)
    Registrant - UNIFIRST FIRST AID CORPORATION (832947092)

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