Label: JUNIOR PAIN AND FEVER FAST DISSOLVING- acetaminophen tablet, chewable

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 8, 2017

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

  • Active ingredient (in each tablet)

    Acetaminophen 160 mg

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  • Purpose

    Pain reliever/fever reducer

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  • Uses

    • temporarily relieves minor aches and pains due to:
      • headache 
      • toothache
      • the common cold
      • sore throat
      • flu
    • temporarily reduces fever
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  • 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 dosage.

    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.

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

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  • Directions

    • this product does not contain directions or complete warnings for adult use
    • do not give more than directed
    • find the right dose on chart below. If possible, use weight to dose; otherwise use age.
    • chew before swallowing; this product will soften in mouth for ease of chewing
    • repeat dose every 4 hours while symptoms last
    • do not give more than 5 times in 24 hours
    • do not give for more than 5 days unless directed by a doctor
    Weight (lb)  Under 48  48-59  60-71  72-95
     Age (yr)  Under 6  6-8  9-10  11
     Dose (tablets)*  Ask a doctor  2  2 1/2  3

    *or as directed by a doctor 

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  • Other information

    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN 
    • store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
    • see end flap for expiration date and lot number
    • avoid high humidity 
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  • Inactive ingredients

    citric acid, crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C blue #1 aluminum lake, flavors, magnesium stearate, mannitol, polyethylene, stearic acid, sucralose

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  • Questions or comments?

    1-800-426-9391

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  • Principal Display Panel

    Well at
    Walgreens
    WALGREENS PHARMACIST RECOMMENDEDǂ

    NDC 0363-4490-08

    Junior
    FAST-DISSOLVING
    Pain
    & Fever
    Acetaminophen
    160 mg / Pain Reliever /
    Fever Reducer
    • Aspirin free  • Ibuprofen free
    • Ages 6 to 11

    24 FAST-DISSOLVING TABLETS

    GRAPE FLAVOR

    Compare to Jr. Strength Tylenol® Meltaways® active ingredientǂǂ

    TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

    ǂWalgreens Pharmacist Survey Study, November 2014.
    ǂǂThis product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Jr. Strength Tylenol® Meltaways®.

    50844    REV0416C44908

    DISTRIBUTED BY: WALGREEN CO.
    200 WILMOT RD., DEERFIELD, IL 60015
    100% SATISFACTION GUARANTEED
    walgreens.com    ©2016 Walgreen Co.

    Walgreens 44-449

    Walgreens 44-449


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  • INGREDIENTS AND APPEARANCE
    JUNIOR PAIN AND FEVER  FAST DISSOLVING
    acetaminophen tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-4490
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 160 mg
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    DEXTRATES (UNII: G263MI44RU)  
    ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color PURPLE Score 2 pieces
    Shape ROUND Size 16mm
    Flavor GRAPE Imprint Code 44;449
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0363-4490-08 4 in 1 CARTON 01/28/2005 07/27/2019
    1 6 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 01/28/2005 07/27/2019
    Labeler - Walgreen Company (008965063)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(0363-4490)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(0363-4490)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 967626305 PACK(0363-4490)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867837 PACK(0363-4490)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 868734088 PACK(0363-4490)
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