Label: CHILDRENS CHEST CONGESTION RELIEF- guaifenesin solution

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

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 December 28, 2021

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 finalpart34101/29/2020
    Labeler - WALGREENS COMPANY (008965063)