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 30, 2023

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  • 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)
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