Label: PREMIER VALUE CHILDRENS ACETAMINOPHEN MELTS- 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 80 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

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

    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.

    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 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 the right dose on chart. 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)

     Age (yr)

     Dose (tablets)*

     Under 24

     Under 2 years

     ask a doctor

     24-35

     2-3 years

     2 tablets

     36-47

     4-5 years

     3 tablets

     48-59

     6-8 years

     4 tablets

     60-71

     9-10 years years

     5 tablets

     72-95

     11

     6 tablets
  • Other information

    •
    store at controlled room temperature 20-25ºC (68-77ºF). Avoid high humidity. Protect from light
    •
    see end flap for expiration date and lot number
  • Inactive ingredients

    citric acid, corn starch, crospovidone, D&C red 30 aluminum lake, dextrose, ethylcellulose, FD&C blue 1 aluminum lake, flavors, gelatin, maltodextrin, magnesium stearate, sucralose

  • Questions or comments?

    1-866-467-2748

  • Product Packaging

    NDC 68016-196-00

    Compare to Children's Tylenol® Meltaways® Active Ingredient*

    Premier Value

    Children's
    Pain Reliever

    Ages 2-6


    ACETAMINOPHEN

    pain reliever/fever reducer
    Aspirin Free/ Ibuprofen Free

    GRAPE FLAVOR

    30 count – 80mg each

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

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

    Premier Value Children's Pain Reliever
  • INGREDIENTS AND APPEARANCE
    PREMIER VALUE CHILDRENS ACETAMINOPHEN MELTS 
    acetaminophen tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-196
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN80 mg
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorPURPLEScoreno score
    ShapeROUNDSize13mm
    FlavorGRAPEImprint Code RP080
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-196-001 in 1 CARTON
    130 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34312/06/2004
    Labeler - Chain Drug Consortium (101668460)
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