GOOD SENSE CHILDRENS MUCUS RELIEF COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [L. PERRIGO COMPANY]

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GOOD SENSE CHILDRENS MUCUS RELIEF COUGH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [L. PERRIGO COMPANY]
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NDC 0113-0419-26
Set ID 9f7cde24-b5f1-4010-b896-dba4c5a1bba9
Category HUMAN OTC DRUG LABEL
Packager L. Perrigo Company
Generic Name
Product Class
Product Number
Application Number PART341
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  • Active ingredients (in each 5 mL)

    Dextromethorphan HBr 5 mg

    Guaifenesin 100 mg

  • Purpose

    Cough suppressant

    Expectorant

  • Uses

    •
    helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
    •
    temporarily relieves:
    •
    cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    •
    the intensity of coughing
    •
    the impulse to cough to help your child get to sleep
  • Warnings

    Do not use

    in a child who is 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 child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

    Ask a doctor before use if the child has

    •
    cough that occurs with too much phlegm (mucus)
    •
    persistent or chronic cough such as occurs with asthma

    Stop use and ask a doctor if

    cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • Directions

    •
    do not take more than 6 doses in any 24-hour period
    •
    measure only with dosing cup provided
    •
    do not use dosing cup with other products
    •
    mL = milliliter

    Age

    Dose

    children 6 years to under 12 years

    5 mL - 10 mL every 4 hours

    children 4 years to under 6 years

    2.5 mL – 5 mL every 4 hours

    children under 4 years

    do not use
  • Other information

    •
    do not use if printed neckband is broken or missing
    •
    store at 20-25°C (68-77°F)
    •
    do not refrigerate
    •
    dosing cup provided
  • Inactive ingredients

    acesulfame potassium, anhydrous citric acid, D&C red #33, FD&C red #40, flavor, glycerin, maltitol solution, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution, xanthan gum

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    Age 4+

    Children’s

    Mucus Relief

    Cough

    Guaifenesin 100 mg

    Expectorant

    Dextromethorphan HBr 5 mg

    Cough Suppressant

    Cough

    Chest Congestion

    Loosens Mucus

    Alcohol-Free

    Cherry Flavor Liquid

    Compare to active ingredients of Children’s Mucinex® Cough

    4 FL OZ (118 mL)

    GoodSense Children's Mucus Relief image 1
    Good Sense Children's Mucus Relief image 2
  • INGREDIENTS AND APPEARANCE
    GOOD SENSE CHILDRENS MUCUS RELIEF COUGH 
    dextromethorphan hydrobromide, guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0113-0419
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Product Characteristics
    ColorRED (Dark Red) Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0113-0419-261 in 1 CARTON11/27/2007
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/27/2007
    Labeler - L. Perrigo Company (006013346)
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