Label: CHILDRENS CHEST CONGESTION- 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 October 21, 2017

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

  • 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 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 Children’s Mucinex® Chest Congestion active ingredient

    children’s Chest Congestion

    GUAIFENESIN / EXPECTORANT

    ALOHOL FREE

    Breaks up the mucus that causes congestion

    AGES 4–12 YEARS

    GRAPE FLAVOR

    4 FL OZ (118 mL)

    childrens chest congestion image
  • INGREDIENTS AND APPEARANCE
    CHILDRENS CHEST CONGESTION 
    guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0288
    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:0363-0288-261 in 1 CARTON08/30/2007
    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 finalpart34108/30/2007
    Labeler - Walgreen Company (008965063)