Label: WALGREENS CHILDRENS COLD PLUS COUGH PLUS RUNNY NOSE- acetaminophen, chlorpheniramine maleate, and dextromethorphan hydrobromide suspension

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

Drug Label Information

Updated November 29, 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

    Chlorpheniramine maleate 1 mg

    Antihistamine

    Dextromethorphan HBr 5 mg

    Cough suppressant
  • Uses

    ▪
    temporarily relieves the following cold/flu symptoms:
    ▪
    minor aches and pains
    ▪
    headache
    ▪
    sore throat
    ▪
    sneezing and runny nose
    ▪
    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.
    ▪
    to make a child sleepy
    ▪
    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
    ▪
    a breathing problem such as chronic bronchitis
    ▪
    glaucoma
    ▪
    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
    ▪
    taking sedatives or tranquilizers

    When using this product

    ▪
    do not exceed recommended dose (see overdose warning)
    ▪
    marked drowsiness may occur
    ▪
    sedatives and tranquilizers may increase drowsiness
    ▪
    excitability may occur, especially in children

    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. (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

    do not use unless directed by a doctor

    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

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

  • Inactive ingredients

    anhydrous citric acid, carboxymethylcellulose sodium, D&C Red No. 33, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, flavors, glycerin, microcrystalline cellulose, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum

  • Questions or comments?

    1-866-467-2748

  • PRINCIPAL DISPLAY PANEL

    Compare to the active ingredients in Children’s Tylenol® Cold + Cough + Runny Nose*

    NDC 0363-7920-04

    Children'sCold + Cough +
    Runny Nose Relief

    Acetaminophen - Pain Reliever-Fever Reducer

    Chlorpheniramine Maleate - Antihistamine
    Dextromethorphan HBr - Cough Suppressant

    Oral Suspension

    Ages 6-11 Years

    •
    Fever
    •
    Sore Throat
    •
    Sneezing
    •
    Runny Nose
    •
    Cough

    Grape Flavor

    Naturally and Artificially Flavored

    4 FL OZ (120 mL)

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

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

    Distributed by:

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

    WAG Childrens Cold plus Cough Plus Runny Nose Relief
  • INGREDIENTS AND APPEARANCE
    WALGREENS CHILDRENS  COLD PLUS COUGH PLUS RUNNY NOSE
    acetaminophen, chlorpheniramine maleate, and dextromethorphan hydrobromide suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-7920
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen160 mg  in 5 mL
    Chlorpheniramine Maleate (UNII: V1Q0O9OJ9Z) (Chlorpheniramine - UNII:3U6IO1965U) Chlorpheniramine Maleate1 mg  in 5 mL
    Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    anhydrous citric acid (UNII: XF417D3PSL)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    D&C red no. 33 (UNII: 9DBA0SBB0L)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C blue no. 1 (UNII: H3R47K3TBD)  
    FD&C red no. 40 (UNII: WZB9127XOA)  
    glycerin (UNII: PDC6A3C0OX)  
    microcrystalline cellulose (UNII: OP1R32D61U)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    water (UNII: 059QF0KO0R)  
    sodium benzoate (UNII: OJ245FE5EU)  
    sorbitol (UNII: 506T60A25R)  
    sucrose (UNII: C151H8M554)  
    xanthan gum (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorPURPLEScore    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-7920-041 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 DrugM01302/24/2023
    Labeler - WALGREENS CO. (008965063)
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