Label: CHEST CONGESTION CHILDRENS- guaifenesin liquid 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 12/12

If you are a consumer or patient please visit this version.

  • Active ingredient (in each 5 mL)

    Guaifenesin, USP 100 mg

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  • Purpose

    Expectorant

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  • Uses

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

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  • 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)

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  • 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

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  • Other information

    store at 20-25°C (68-77°F)
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  • 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

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  • Questions or comments?

    1-800-719-9260

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  • Principal Display Panel

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

    Children’s

    Mucus relief

    CHEST CONGESTION

    EXPECTORANT

    GUAIFENESIN

    Relieves chest congestion

    Thins & loosens mucus

    Alcohol free

    Gluten free

    GRAPE FLAVOR LIQUID

    Children's Chest Congestion Carton Image 1
    Children's Chest Congestion Carton Image 2
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  • INGREDIENTS AND APPEARANCE
    CHEST CONGESTION  CHILDRENS
    guaifenesin liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59779-288
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 100 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    ACESULFAME POTASSIUM  
    ANHYDROUS CITRIC ACID  
    FD&C BLUE NO. 1  
    FD&C RED NO. 40  
    GLYCERIN  
    PROPYLENE GLYCOL  
    WATER  
    SACCHARIN SODIUM  
    SODIUM BENZOATE  
    SORBITOL  
    SUCRALOSE  
    XANTHAN GUM  
    Product Characteristics
    Color PURPLE (clear) Score     
    Shape Size
    Flavor GRAPE Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59779-288-26 1 in 1 CARTON
    1 118 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 03/11/2009
    Labeler - CVS Pharmacy (062312574)
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