Label: CHILDRENS MUCINEX CHEST CONGESTION- guaifenesin liquid 

  • 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 11/12

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Close
  • Active ingredient (in each 5 mL)

    Guaifenesin, USP 100 mg

    Close
  • Purpose

    Expectorant

    Close
  • Uses

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

    Close
  • 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.

    Close
  • 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
    Close
  • Other information

    • tamper evident: do not use if printed neckband on bottle cap is broken or missing
    • store between 20-25°C (68-77°F)
    • do not refrigerate
    • dosing cup provided
    Close
  • Inactive ingredients

    acesulfame potassium, anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, maltitol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol, sucralose, xanthan gum

    Close
  • Questions?

    1-866-MUCINEX (1-866-682-4639)

    You may also report side effects to this phone number.

    Close
  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

    NDC 63824-280-64

    Children's
    Mucinex®

    Chest
    Congestion

    Guaifenesin Oral Solution, USP
    Expectorant

    Chest Congestion
    Breaks up Mucus
    Alcohol-free

    Grape
    Flavor Liquid

    4 FL OZ
    (118 mL)

    Principal Display Panel - 118 mL Bottle Carton
    Close
  • INGREDIENTS AND APPEARANCE
    CHILDRENS MUCINEX CHEST CONGESTION 
    guaifenesin liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:63824-280
    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  
    maltitol  
    propylene glycol  
    water  
    saccharin sodium  
    sodium benzoate  
    sorbitol  
    sucralose  
    xanthan gum  
    Product Characteristics
    Color PURPLE Score     
    Shape Size
    Flavor GRAPE Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63824-280-64 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 07/01/2011
    Labeler - Reckitt Benckiser LLC (094405024)
    Close