Label: CAREONE MUCUS RELIEF CHILDRENS- guaifenesin solution

  • NDC Code(s): 41520-288-26
  • 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 October 17, 2017

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  • Active ingredient (in each 5 mL)

    Guaifenesin 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 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, FD&C blue #1, FD&C red #40, flavor, glycerin, maltitol solution, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution, sucralose, xanthan gum

    Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    Compare to the active ingredient in Children’s Mucinex® Chest Congestion

    For Ages 4 And Older

    Children’s

    MUCUS RELIEF

    CHEST CONGESTION

    Expectorant - Guaifenesin 100mg

    FOR RELIEF OF:

    Chest Congestion

    Breaks Up Mucus

    Alcohol Free

    Gluten Free

    OUR PHARMACISTS RECOMMEND

    Grape Flavor

    4 FL OZ (118mL)

    childrens mucus relief image
  • INGREDIENTS AND APPEARANCE
    CAREONE MUCUS RELIEF  CHILDRENS
    guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-288
    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
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    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)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorPURPLE (clear) Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-288-261 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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