Label: CHILDRENS MUCUS AND COUGH RELIEF- guaifenesin and dextromethorphan hydrobromide liquid

  • NDC Code(s): 63868-771-04
  • Packager: Chain Drug Manufacturing Assn
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 9, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 5 mL)

    Purposes

    Dextromethorphan HBr 5 mg

    Cough suppressant

    Guaifenesin 100 mg

    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 illness.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 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
    AgeDose

    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

    ▪
    each 5 mL contains: sodium 3 mg
    ▪
    Tamper -evident: do not use if printed inner seal under cap is torn or missing
    ▪
    store at room temperature
    ▪
    do not refrigerate
    ▪
    dosing cup provided
  • Inactive ingredients

    Anhydrous citric acid, edetate disodium, FD&C Red#40, flavors, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

    NDC 63868-771-04

    Compare to the Active ingredient in Children’s Mucinex Cough*

    Children's

    Mucus &Cough Relief

    Cough Suppressant

    Expectorant

    Dextromethorphan HBr

    Guaifenesin

    Each Dose of Cherry Flavored

    Children's

    Mucus & Cough Relief:

    Controls Cough
    Relieves Chest Congestion
    Breaks up Mucus


    Alcohol-free

    See New Dosing information

    Cherry
    Flavor

    4 FL OZ
    (118 mL)

    IMPORTANT: Keep this carton for future reference on full labeling.

    DOSAGE CUP INCLUDED

    Distributed by C.D.M.A., Inc©

    43157 W. Nine Mile

    Novi, MI 48376-0995

    www.qualitychoice.com

    Questions: 248-449-9300

    *This product is not manufactured or distributed by Reckitt Benckiser, distributor of Children’s Mucinex.®

    QC 100% Satisfaction Guaranteed.

    Quality Choice Children's Mucus and Cough Relief Cherry Flavor 4 FL OZ
  • INGREDIENTS AND APPEARANCE
    CHILDRENS MUCUS AND COUGH RELIEF 
    guaifenesin and dextromethorphan hydrobromide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-771
    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
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-771-041 in 1 CARTON10/19/2015
    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 DrugM01210/19/2015
    Labeler - Chain Drug Manufacturing Assn (011920774)
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