Label: CAREONE CHILDRENS MUCUS RELIEF- dextromethorphan hbr, guaifenesin solution

  • NDC Code(s): 41520-419-26
  • Packager: American Sales Company
  • Category: HUMAN OTC DRUG LABEL

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 May 1, 2018

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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

    Compare to the active ingredients in Children’s Mucinex® Cough

    For Ages 4 And Older

    Children’s

    MUCUS RELIEF

    COUGH

    Cough Suppressant – Dextromethorphan HBr 5mg

    Expectorant – Guaifenesin 100mg

    FOR RELIEF OF:

    Cough

    Chest Congestion

    Loosens Mucus

    Alcohol Free

    Gluten Free

    OUR PHARMACISTS RECOMMEND

    Cherry Flavor

    4 FL OZ (118mL)

    childrens-mucus-relief-image
  • INGREDIENTS AND APPEARANCE
    CAREONE CHILDRENS MUCUS RELIEF 
    dextromethorphan hbr, guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-419
    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:41520-419-261 in 1 CARTON08/08/2007
    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 finalpart34108/08/2007
    Labeler - American Sales Company (809183973)
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