Label: WALGREEN CHILDRENS PAIN PLUS FEVER- acetaminophen suspension

  • NDC Code(s): 0363-6958-08, 0363-6958-16
  • Packager: WALGREENS CO.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 12, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 5 mL)

    Acetaminophen 160 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    ▪
    temporarily:
    ▪
    reduces fever
    ▪
    relieves minor aches and pains due to:
    ▪
    the common cold
    ▪
    flu
    ▪
    headache
    ▪
    sore throat
    ▪
    toothache
  • 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.
    ▪
    if your child is allergic to acetaminophen or any of the inactive ingredients in this product

    Ask a doctor before use if your child has liver disease

    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 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

    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 24 lbs

    under 2 years

    ask a doctor

    24-35 lbs

    2-3 years

    5 mL

    36-47 lbs

    4-5 years

    7.5 mL

    48-59 lbs

    6-8 years

    10 mL

    60-71 lbs

    9-10 years

    12.5 mL

    72-95 lbs

    11 years

    15 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 2 mg
    ▪
    store at room temperature
  • Inactive ingredients

    anhydrous citric acid, carboxymethylcellulose sodium, 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 ingredient in Children’s Tylenol® Dye-Free Oral Suspension*

    NDC 0363-6958-08

    Children’s

    Pain+Fever

    Relief

    Acetaminophen
    Oral Suspension


    Pain Reliever-Fever Reducer

    •
    Dye-Free
    •
    No Added Alcohol
    •
    Sugar Free

    For Ages 2-11 Years

    Cherry Flavor
    Naturally Flavored

    8 FL. OZ. (240 mL)
    160 mg per 5 mL

    *This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., distributor of Children’s Tylenol® Dye-Free Oral Suspension.

    Distributed By:

    Package Label for 8 FL OZ (240 mL)

    WAG Children's Pain+ Fever Relief Acetaminophen Oral Suspension

    Package Label for 16 FL OZ (480 mL)

    WAG Children's Pain+ Fever Relief Acetaminophen Oral Suspension TWIN PACK
  • INGREDIENTS AND APPEARANCE
    WALGREEN CHILDRENS PAIN PLUS FEVER 
    acetaminophen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-6958
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    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
    ColorREDScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-6958-081 in 1 PACKAGE02/24/2023
    1240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:0363-6958-162 in 1 PACKAGE02/24/2023
    2240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    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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