Label: JUNIOR STRENGTH PAIN RELIEVER- acetaminophen tablet, chewable 

  • Label RSS
  • NDC Code(s): 63941-449-08
  • Packager: VALUE MERCHANDISERS COMPANY, INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 07/13

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:
      • the common cold
      • flu
      • headache
    • 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

    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. Quick medical attention is critical 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
    • 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)  Age (yr)  Tablets
     under 48  under 6  Ask a doctor
     48-59  6-8  2
     60-71  9-10  2 1/2
     72-95  11  3
     96 and over  12  4
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  • Other information

    • store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
    • see end flap for expiration date and lot number
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  • Inactive ingredients

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

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  • Questions or comments?

    1-800-426-9391

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  • Product Packaging

    Best Choice® Brand
    HEALTH CARE

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

    Grape Flavor

    Jr. Strength

    AGES 6-11

    PAIN RELIEVER RAPID MELTS
    contains Acetaminophen

    Pain Reliever/Fever Reducer

    Aspirin Free • Ibuprofen Free

    24 Quick Melts -160 mg

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Junior Strength Tylenol® Meltaways®.
     50844       REV1012C44908

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

    Best Choice 44-449

    Best Choice 44-449

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  • INGREDIENTS AND APPEARANCE
    JUNIOR STRENGTH PAIN RELIEVER 
    acetaminophen tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:63941-449
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 160 mg
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE  
    CROSPOVIDONE  
    D&C RED NO. 27  
    D&C RED NO. 30  
    DEXTROSE  
    ETHYLCELLULOSES  
    FD&C BLUE NO. 1  
    MAGNESIUM STEARATE  
    MANNITOL  
    STEARIC ACID  
    SUCRALOSE  
    Product Characteristics
    Color PURPLE Score no score
    Shape ROUND Size 16mm
    Flavor GRAPE Imprint Code 44;449
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63941-449-08 1 in 1 CARTON
    1 24 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 01/28/2005
    Labeler - VALUE MERCHANDISERS COMPANY, INC. (868703513)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(63941-449)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(63941-449)
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