Label: WALGREEN CHILDRENS COLD PLUS COUGH PLUS SORE THROAT- acetaminophen and dextromethorphan hydrobromide suspension

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

Drug Label Information

Updated November 12, 2024

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 5 mL)Purposes

    Acetaminophen 160 mg

    Pain reliever/fever reducer

    Dextromethorphan HBr 5 mg

    Cough suppressant

  • Uses

    temporarily relieves the following cold/flu symptoms:
    minor aches and pains
    headache
    sore throat
    cough
    temporarily reduces fever
  • 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.
    if your child has ever had an allergic reaction to this product or any of its ingredients

    Ask a doctor before use if your child has

    liver disease
    persistent or chronic cough such as occurs with asthma
    cough that occurs with too much phlegm (mucus)

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

    When using this product

    do not exceed recommended dose (see overdose warning)

    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
    new symptoms occur
    redness or swelling is present
    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.

    Overdose warning

    In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    this product does not contain directions or complete warnings for adult use
    do not give more than directed (see overdose warning)
    shake well before using
    mL = milliliter
    find right dose on chart below. If possible, use weight to dose; otherwise, use age.
    remove the child protective cap and squeeze your child's dose into the dosing cup
    repeat dose every 4 hours, while symptoms last
    do not give more than 5 times in 24 hours
    Weight (lb)Age (yr)Dose (mL)

    under 36

    under 4 years

    do not use

    36-47

    4 to 5 years

    5 mL

    48-95

    6 to 11 years

    10 mL

    Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

  • Other information

    each 5 mL contains: sodium 3 mg
    store at room temperature
  • Inactive ingredients

    carboxymethylcellulose sodium, anhydrous citric acid, D&C red no. 33, disodium edetate, FD&C red no. 40, flavors, glycerin, microcrystalline cellulose, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol solution, sucralose, xanthan gum

  • Questions or comments?

    1-866-467-2748

  • PRINCIPAL DISPLAY PANEL

    Compare to the active ingredients in Children’s Tylenol® Cold + Cough + Sore Throat*

    NDC 0363-6504-04

    Children's

    Cold + Cough

    + Sore Throat Relief

    Acetaminophen, Pain Reliever-Fever Reducer
    Dextromethorphan HBr, Cough Suppressant

    Oral Suspension

    Ages 4-11 Years

    Fever
    Sore Throat
    Cough

    Ibuprofen free, aspirin free,

    No added alcohol

    BubblegumFlavor

    Naturally and Artificially Flavored

    4 FL OZ (120 mL)

    *This product is not manufactured or distributed by Johnson & Johnson Consumer Inc, distributor of Children’s Tylenol® Cold + Cough + Sore Throat.

    TAMPER-EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAPS IS TORN OR MISSING.

    Walgreens Children's Cold + Cough + Sore Throat Relief 4 FL OZ 120 mL
  • INGREDIENTS AND APPEARANCE
    WALGREEN CHILDRENS  COLD PLUS COUGH PLUS SORE THROAT
    acetaminophen and dextromethorphan hydrobromide suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-6504
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorpinkScore    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-6504-041 in 1 CARTON02/24/2023
    1120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01202/24/2023
    Labeler - WALGREENS CO. (008965063)