Label: MUCINEX CHILDRENS FEVER SORE THROAT AND COUGH- acetaminophen, dextromethorphan hydrobromide solution

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

Drug Label Information

Updated April 3, 2024

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

  • Drug Facts

  • Active ingredients / Purpose (in each 10 mL)

    Acetaminophen 325 mg..Pain reliever/fever reducer
    Dextromethorphan HBr 10 mg....Cough suppressant

  • PURPOSE

    Acetaminophen 325 mg..Pain reliever/fever reducer
    Dextromethorphan HBr 10 mg....Cough suppressant

  • Uses

    ■ 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
    ■ minor aches and pains
    ■ sore throat
    ■ headache
    ■ temporarily reduces fever

  • WARNINGS

    Warnings
    Liver warning: This product contains
    acetaminophen. Severe liver damage may occur if
    your child takes:
    ■ more than 5 doses in 24 hours, which is the
    maximum daily amount
    ■ with other drugs containing acetaminophen
    Allergy alert: Acetaminophen may cause severe
    skin reactions. Symptoms may include:
    ■ skin reddening

    ■ blisters

    ■ rash


    If a skin reaction occurs, stop use and seek medical help
    right away.


    Sore throat warning: If sore throat is severe, persists
    for more than 2 days, is accompanied or followed by fever,
    headache, rash, nausea, or vomiting, consult a doctor
    promptly.

    Do not use
    ■ with any other drug containing acetaminophen
    (prescription or nonprescription). If you are not
    sure whether a drug contains acetaminophen,
    ask a doctor or pharmacist.
    ■ 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 DOCTOR

    Ask a doctor before use if the child has
    ■ liver disease
    ■ chronic cough that lasts such as occurs with
    asthma
    ■ cough that occurs with too much phlegm
    (mucus)

    Ask a doctor or pharmacist before use if the child is
    taking the blood thinning drug warfarin

    Stop use and ask a doctor if
    ■ pain or cough gets worse or lasts more than
    5 days
    ■ fever gets worse or lasts more than 3 days
    ■ redness or swelling is present
    ■ new symptoms occur
    ■ cough comes back or occurs with rash or
    headache that lasts. These could be signs of a
    serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.


    Overdose warning: Taking more than the recommended
    dose (overdose) may cause liver damage. In case of
    overdose, get medical help or contact a Poison Control
    Center right away. Quick medical attention is critical even
    if you do not notice any signs or symptoms

  • Directions

    Directions
    ■ this product does not contain directions or complete
    warnings for adult use
    ■ do not give more than directed (see Overdose
    warning)
    ■ measure only with dosing cup provided
    ■ do not use dosing cup with other products
    ■ dose as follows or as directed by a doctor
    ■ children 6 to under 12 years of age: 10 mL in
    dosing cup provided every 4 hours while
    symptoms last; do not give more than 5 doses in
    any 24-hour period
    ■ children under 6 years of age: do not use

  • OTHER SAFETY INFORMATION

    Other information
    ■ each 10 mL contains: sodium 6 mg
    ■ store at 20-25°C (68-77°F)
    ■ do not refrigerate

  • INACTIVE INGREDIENT

    Inactive ingredients: anhydrous citric acid,
    D&C yellow no. 10, edetate disodium, FD&C red
    no. 40, flavors, glycerin, propylene glycol,
    purified water, sodium benzoate, sorbitol,
    sucralose, xanthan gum

  • QUESTIONS

    Questions? 1-866-682-4639

  • PRINCIPAL DISPLAY PANEL

    NDC 72854-064

    Children's
    Mucinex®

    Honey
    Flavor Liquid

    4 FL OZ
    (118 mL)

    Label

  • INGREDIENTS AND APPEARANCE
    MUCINEX CHILDRENS FEVER SORE THROAT AND COUGH 
    acetaminophen, dextromethorphan hydrobromide solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72854-064
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 10 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorHONEYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72854-064-041 in 1 CARTON05/01/2024
    1118 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01205/01/2024
    Labeler - RB Health (US) LLC (081049410)