Label: CHILDREN PAIN AND FEVER RELIEVER- 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 October 31, 2022

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  • Active ingredient (in each chewable tablet)

    Acetaminophen 160 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    ▪
    temporarily relieves minor aches and pains due to:
    ▪
    the common cold
    ▪
    flu
    ▪
    headache
    ▪
    sore throat
    ▪
    toothache
    ▪
    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 reaction. Symptoms may include:

    ▪
    skin reddening
    ▪
    blister
    ▪
    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 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.
    ▪
    chew completely do not swallow whole
    ▪
    repeat dose every 4 hours while symptoms last
    ▪
    do not give more than 5 times in 24 hours or as directed by a doctor

    Weight (lbs)

    under 24

    24-35

    36-47

    48-59

    60-71

    72-95

    Age (yr)

    under 2 years

    2-3 years

    4-5 years

    6-8 years

    9-10 years

    11 years

    Dose (Tablets)

     ask a doctor

     1 tablet

    1 ½ tablets

    2 tablets

    2 ½ tablets

    3 tablets
  • Other information

    •
    store at room temperature. Avoid high humidity. Protect from light
    •
    see end flap for expiration date and lot number
  • Inactive ingredients

    citric acid, crospovidone, D&C Red no. 30 Lake, dextrose, FD&C Blue No. 1 Lake, flavors, hydroxypropylcellulose, magnesium stearate, maltodextrin, silicon dioxide, sodium carboxymethyl cellulose, starch, sucralose

    Questions or comments?

    1-866-467-2748

  • Principal Display Panel

    NDC 11673-241-24

    Compare to active ingredient in Children’s Tylenol® Chewables*

    children’s acetaminophen

    chewable tabs, 160 mg

    up & up

    pain reliever/fever reducer

    aspirin free

    ibuprofen free
    Ages 2-11 YEARS

    GRAPE FLAVOR

    Naturally and Artificially Flavored

    24 CHEWABLE TABLETS 160 mg each

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

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

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark children’s Tylenol® Chewable.

    50844 REV0213F44908

    094 01 0603 R03 ID225450

    Distributed by Target Corporation

    Minneapolis,MN 55403

    © 2019 Target Brands,Inc.

    Shop Target.com

    Children's Pain Fever Chewables Grape Flavor 24 Tablets
  • INGREDIENTS AND APPEARANCE
    CHILDREN PAIN AND FEVER RELIEVER 
    acetaminophen tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-241
    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 (120 .MU.M) (UNII: 68401960MK)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorPURPLEScore2 pieces
    ShapeROUNDSize16mm
    FlavorGRAPEImprint Code RP160
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-241-244 in 1 CARTON11/11/2019
    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 finalpart34311/11/2019
    Labeler - Target Corporation (006961700)
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