Label: UP AND UP JUNIORS ACETAMINOPHEN- 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 January 16, 2015

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  • Active ingredient (in each tablet)

    Acetaminophen 160 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    •
    temporarily relieves minor aches and pains due to:
    •
    the common cold
    •
    flu
    •
    headache
    •
    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.

    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: Taking more than the recommended dose (overdose) may cause liver damage. 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 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 the right dose on chart below. If possible, use weight to dose; otherwise use age.
    •
    dissolve in mouth or chew before swallowing
    •
    if needed, 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

    96 and over

    Age (yr)

    under 6 years

    6-8 years

     9-10 years

    11 years

    12 years

    Tablets

     ask a doctor

     2

    2 1/2

    3

    4
  • Other information

    •
    store at between 20º-25ºC (68º-77ºF). Avoid high humidity.
    •
    see end flap for expiration date and lot number
  • Inactive ingredients

    citric acid, corn starch, crospovidone, red no. 27 aluminum lake, dextrose, ethylcellulose, flavors, gelatin, maltodextrin, magnesium stearate, sucralose

    Questions or comments ?

    1-800-910-6874

  • Principal Display Panel

    NDC 11673-160-31

    Compare to active ingredient in Junior Strength Tylenol® Meltaways®*

    juniors’

    acetaminophen

    melty tabs,160 mg

    pain reliever/fever reducer

    aspirin-free

    ibuprofen-free

    AGES 6-11 YEARS

    BUBBLEGUM FLAVOR

    24 CHEWABLE TABLETS

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

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Junior Strength Tylenol® Meltaways®.

    50844 REV1013G45008

    094 01 0307 R01 ID225450

    Distributed by Target Corporation

    Minneapolis, MN 55403

    © 2014 Target Brands, Inc.

    Shop Target.com

    up and up juniors acetaminophen
  • INGREDIENTS AND APPEARANCE
    UP AND UP JUNIORS ACETAMINOPHEN 
    acetaminophen tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-160
    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)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE (UNII: 68401960MK)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)  
    GELATIN (UNII: 2G86QN327L)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorPINKScore2 pieces
    ShapeROUNDSize16mm
    FlavorBUBBLE GUMImprint Code RP160
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-160-314 in 1 CARTON
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34310/19/2015
    Labeler - Target Corporation (006961700)
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