JUNIOR ACETAMINOPHEN AGES 6-11 (ACETAMINOPHEN) TABLET, ORALLY DISINTEGRATING [CHAIN DRUG CONSORTIUM]

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JUNIOR ACETAMINOPHEN AGES 6-11 (ACETAMINOPHEN) TABLET, ORALLY DISINTEGRATING [CHAIN DRUG CONSORTIUM]
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NDC 68016-198-00
Set ID d356bc9c-66f1-45c3-a455-98c0b8890f78
Category HUMAN OTC DRUG LABEL
Packager Chain Drug Consortium
Generic Name
Product Class
Product Number
Application Number PART343
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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

    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 dosage (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

     Weight (lbs)

     Age (yr)

     Tablets

     under 24

     under 2 years

     Ask a doctor

     24-35

     2-3 years

     1 tablets

     36-47

     4-5 years

     1½ tablets

     48-59

    60-71

    72-95

    6-8 years

    9-10 years

    11 years

     2 tablets

    2½ tablets

    3 tablets

    *or as directed by a doctor

  • 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

  • Principal Display Panel

    COMPARE TO ACTIVE INGREDIENT IN CHILDREN’S TYLENOL® CHEWABLES*

    Premier Value®

    Children’s Pain Reliever Chewables


    ACETAMINOPHEN
    Pain Reliever/Fever Reducer

    Aspirin-Free

    Ibuprofen-Free

    Grape Flavor

    Naturally and Artificially Flavored


    24 CHEWABLES 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

    Distributed by

    Pharmacy Value Alliance, LLC

    407 East Lancaster Avenue, Wayne, PA

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

    Premier Value Junior Pain Reliever 24ct
  • INGREDIENTS AND APPEARANCE
    JUNIOR ACETAMINOPHEN  AGES 6-11
    acetaminophen tablet, orally disintegrating
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-198
    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)  
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorPURPLEScore2 pieces
    ShapeROUNDSize16mm
    FlavorGRAPEImprint Code RP160
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-198-004 in 1 CARTON08/07/2015
    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 finalpart34308/07/2015
    Labeler - Chain Drug Consortium (101668460)
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