Label: CHILDRENS PAIN AND FEVER DISSOLVE PACKS- acetaminophen powder

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

Drug Label Information

Updated November 28, 2023

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each packet)

    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)
    find right dose on chart. If possible, use weight to dose; otherwise, use age.
    tear packet and pour powder on your child's tongue
    repeat dose every 4 hours while symptoms last
    do not give more than 5 times in 24 hours
    Weight (lb)Age (yrs.)Dose (packets)**

    under 48

    under 6 years

    do not use

    48-59

    6-8 years

    2 packets

    60-71

    9-10 years

    2 packets

    72-95

    11 years

    3
    packets
  • Other information

    store at room temperature

    TAMPER EVIDENT: DO NOT USE IF PACKET IS TORN OR DAMAGED

  • Inactive ingredients

    citric acid, flavor, gelatin, isomalt, silica, sucralose

  • Questions?

    1-866-467-2748

  • PRINCIPAL DISPLAY PANEL

    NDC 0363-5101-18

    Children's

    Dye-Free

    Pain & Fever Dissolve Packs

    ACETAMINOPHEN 160 mg
    PAIN RELIEVER/FEVER REDUCER

    DYE FREE, ASPIRIN FREE, IBUPROFEN FREE

    No water needed
    Dissolves in seconds

    AGES 6-11 YEARS

    18 PACKETS*
    160 mg EACH PACKET

    WILD BERRY FLAVOR

    NATURALLY AND ARTIFICIALLY FLAVORED

    *PACKETS OF POWDER

    Pour powder on your child’s tongue

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

    Walgreens Pharmacist Recommended

    Walgreens Pharmacist Survey

    ††This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of the registered trademark Children’s Tylenol® Dissolve Packs.

    Distributed by:

    WALGREEN CO.

    200 WILMOT RD., CEERFIELD, IL 60015

    100% SATISFACTION GUARANTEED

    walgreens.com © 2020 Walgreen Co.

    Walgreens Dye-Free Pain and Fever Dissolve Packs
  • INGREDIENTS AND APPEARANCE
    CHILDRENS PAIN AND FEVER  DISSOLVE PACKS
    acetaminophen powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-5101
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen160 mg
    Inactive Ingredients
    Ingredient NameStrength
    citric acid monohydrate (UNII: 2968PHW8QP)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    ISOMALT (UNII: S870P55O2W)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    sucralose (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorWHITE (off white) Score    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-5101-1818 in 1 CARTON01/29/2020
    11 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01301/29/2020
    Labeler - WALGREENS CO. (008965063)