Label: CHILDRENS MUCUS RELIEF CHEST CONGESTION- guaifenesin solution

  • NDC Code(s): 63868-770-04
  • Packager: Chain Drug Manufacturing Assn
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 9, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 5 mL)

    Guaifenesin, USP 100 mg

  • Purpose

    Expectorant

  • Uses

    helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

  • Warnings

    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.

  • 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 Blue #1, FD&C Red #40, flavors, potassium citrate propylene glycol, purified water, sodium benzoate ,sorbitol, sucralose, xanthan gum.

  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

    QC QUALITY CHOICE NDC 63868-770-04

    Children's
    Mucus relief

    Expectorant

    Guaifenesin

    Oral Solution, USP

    Each Dose of Grape Flavored

    Children’s Mucus Relief:

    Relieves Chest Congestion

     
    Breaks up Mucus


    Alcohol Free

     
    See New Dosing Information

    Grape
    Flavor

    4 FL OZ
    (118 mL)

    IMPORTANT:

    Keep this carton for future reference on full labeling.

    DOSAGE CUP INCLUDED

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

    Distributed by C.D.M.A.,Inc©

    43157 W. Nine Mile

    Novi, MI 48376-0995

    www.qualitychoice.com

    Questions: 248-449-9300

    QC 100% Satisfaction Guaranteed.

    Quality Choice Childrens Mucus Relief Expectorant Grape Flavor 4 FL OZ
  • INGREDIENTS AND APPEARANCE
    CHILDRENS MUCUS RELIEF  CHEST CONGESTION
    guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-770
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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 blue no. 1 (UNII: H3R47K3TBD)  
    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
    ColorPURPLEScore    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-770-041 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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