Label: CHILDRENS MUCUS AND COUGH RELIEF- dextromethorphan hydrobromide and 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 October 4, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 5 mL)

    Purpose

    Dextromethorphan HBr 5 mg

    Cough suppressant

    Guaifenesin 100 mg

    Expectorant
  • Uses

    ▪
    helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
    ▪
    temporarily relieves:
    ▪
    cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    ▪
    the intensity of coughing
    ▪
    the impulse to cough to help your child get to sleep
  • Warnings

    Do not use in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

    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
    ▪
    Tamper evident: do not use if printed inner seal under cap is torn or missing
    ▪
    store at room temperature
    ▪
    do not refrigerate
    ▪
    dosing cup provided
  • Inactive ingredients

    anhydrous citric acid, edetate disodium, FD&C red #40, flavors, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

  • Questions or comments?

    1-866-467-2748

  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

    LEADER™

    NDC 70000-0131-1

    Children's Mucus and Cough Relief

    Dextromethorphan HBr , 5 mg

    Guaifenesin, 100 mg

    Cherry
    Flavor

    AGES 4-12 YEARS

    Controls Cough
    Relieves Chest Congestion
    Breaks up Mucus


    COMPARE TO CHILDREN’S MUCINEX® COUGH active ingredients

    100% Money Back Guarantee

    Dosing Cup included

    4 FL OZ
    (118 mL)

     
    © CARDINAL HEALTH, the Cardinal Health LOGO, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health.

    *This product is not manufactured or distributed by Reckitt Benckiser, owner of the registered trademark Children’s Mucinex® Cough.

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

    DISTRIBUTED BY CARDINAL HEALTH

    DUBLIN, OHIO 43017

    www.myleader.com

    1-800-200-6313

    Essential to Care™ since 1979

    All Leader Brand Products have a 100% Money Back Guarantee

    Return to place of purchase if not satisfied

    Children's Mucus and Cough Relief 4 FL OZ Cherry Flavor
  • INGREDIENTS AND APPEARANCE
    CHILDRENS MUCUS AND COUGH RELIEF 
    dextromethorphan hydrobromide and guaifenesin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0131
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    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
    ColorREDScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0131-11 in 1 CARTON05/05/2017
    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 finalpart34105/05/2017
    Labeler - CARDINAL HEALTH (063997360)
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