Label: CHILDRENS MUCUS RELIEF CHEST CONGESTION- guaifenesin liquid

  • 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 11, 2019

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each 5 mL)
    Guaifenesin, USP                           100 mg

  • PURPOSE

    Purpose
    Guaifenesin, USP ......................................... Expectorant

  • INDICATIONS & USAGE

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

  • WARNINGS

    Warnings
    Ask a doctor before use if the child has
    • cough that occurs with too much phlegm (mucus)
    • cough that lasts or is chronic such as occurs with asthma

  • WHEN USING

    When using this product
    • do not use more than directed

  • STOP USE

    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

    Keep out of reach of children. In case of overdose, get medical
    help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • do not take more than 6 doses in any 24-hour period
    • mL =milliliter
    Age                                               Dose

     Children 6 years to under

     12 years

     5 mL - 10 mL every 4 hours
     Children under 6 years Do not use

  • OTHER SAFETY INFORMATION

    Other information
    each 5 mL contains: sodium 3 mg
    • store between 20-25°C (68-77°F)
    • do not refrigerate
    • dosing cup provided

  • INACTIVE INGREDIENT

    Inactive ingredients
    Anhydrous citric acid, flavor, purified water, sodium
    benzoate, sucrose

  • QUESTIONS

    Questions? Call weekdays from 9:30 AM to 4:30 PM
    EST at 1-877-798-5944

  • Principal Display Package

    CVS
    HealthTM

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

    Children's
    Mucus Relief
    Chest
    Congestion

    Free of alcohol, dyes &
    artificial sweeteners

    GUAIFENESIN ORAL SOLUTION, USP
    Expectorant

    Relieves:
    Chest congestion

    Thins & loosens
    mucus

    Cherry Flavor

    For Ages
    6 to 12 Years

    8 FL OZ (237 mL)

    DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN
    Failure to follow these warnings could result in serious consequences

    DO NOT REFRIGERATE. STORE AT ROOM TEMPERATURE.

    *This product is not manufactured or distributed by
    Reckitt Benckiser, distributor of Children's Mucinex®
    Chest Congestion.

    Lot:
    Exp:

    LR-114 REV 01 #338983

    0 50428 61657 4

    CONTINUED →
    ON BACK

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895
    © 2018 CVS/pharmacy
    CVS.com® 1-800-SHOP CVS
    V-34690

    √CVS Quality
    Money Back Guarantee

    Product Package

    318-26-Label

                                   Children's Mucus Relief, by CVS Pharmacy, Inc.

    res

  • INGREDIENTS AND APPEARANCE
    CHILDRENS MUCUS RELIEF CHEST CONGESTION 
    guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76281-318
    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)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76281-318-26237 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/01/2018
    Labeler - AptaPharma Inc. (790523323)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(76281-318)