Label: CHILDRENS CHEST CONGESTION RELIEF- guaifenesin solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 29, 2023

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

  • 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
    store at room temperature
    do not refrigerate
    dosing cup provided
  • Inactive ingredients

    anhydrous citric acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, natural and artificial flavors, potassium citrate propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

  • Principal Display Panel - 120 mL

    NDC 0363-7504-04

    Compare to Children’s Mucinex® Chest Congestion active ingredient††

    children's

    Chest Congestion Relief

    GUAIFENESIN 100 mg

    ORAL SOLUTION, USP/

    EXPECTORANT

    ALCIHOL FREE

    Breaks up the mucus that causes congstion

    AGES 4 YEARS & OLDERS

    GRAPE FLAVOR

    NATURALLY AND ARTIFICIALLY FLAVORED

    4 FL OZ (120 mL)

    IMPORTANT: Keep this carton for future reference on full labeling.

    †Walgreens Pharmacist Survey

    ††This product is not manufactured or distributed by Reckitt Benckiser, distributor of Children’s Mucinex® Chest Congestion

    DISTRIBUTED BY:

    WALGREEN CO.

    200 WILTMOT RD. DEERFIELD, IL 60015

    Walgreens

    100% SATISFACTION GUARANTEED

    walgreen.com ©2020 Walgreens Co.

    Walgreens Childrens Chest Congestion Relief Grape Flavor
  • INGREDIENTS AND APPEARANCE
    CHILDRENS CHEST CONGESTION RELIEF 
    guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-7504
    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:0363-7504-041 in 1 CARTON01/29/2020
    1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01201/29/2020
    Labeler - WALGREENS COMPANY (008965063)