Label: CHILDRENS PAIN RELIEF- acetaminophen tablet, chewable

  • 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 03/11

If you are a consumer or patient please visit this version.

  • Active ingredient

     (in each tablet)

    Acetaminophen 80 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
    • headache
    • flu
    • sorethroat
    • toothache
    • 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 warning for adult use
    • find the right dose on chart. 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 24  under 2  Ask a doctor
     24-35  2-3  2
     36-47  4-5  3
     48-59  6-8  4
     60-71  9-10  5
     72-95  11  6
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  • Other information

    • store at controlled room temperature 15°-30°C (59°-86°F)
    • see end flap for expiration date and lot number
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  • Inactive ingredients

    citric acid, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrose, ethylcellulose, flavors, magnesium stearate, mannitol, polyethylene, povidone, stearic acid, sucralose

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  • Questions or comments?

    1-800-426-9391

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  • Product Packaging

    The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

    DG™

    health

    Compare to active ingredient in Children's Tylenol® Meltaways*

    For Ages 2-11

    SEE NEW WARNINGS INFORMATION

    Children's

    Rapid Melts

    Acetaminophen

    Pain Reliever / Fever Reducer

    • Ibuprofen free

    • Aspirin free

    Bubble Gum Flavor

    DG Quality Guaranteed

    30

    80 mg Tablets

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

    50844       REV0410B44701

    DISTRIBUTED BY DOLGENCORP, LLC

    100 MISSIONS RIDGE

    GOODLETTSVILLE, TN 37073

    Product Packaging

    Product Packaging

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  • INGREDIENTS AND APPEARANCE
    CHILDRENS PAIN RELIEF 
    acetaminophen tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55910-447
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 80 mg
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE  
    D&C RED NO. 27  
    D&C RED NO. 30  
    DEXTROSE  
    ETHYLCELLULOSES  
    MAGNESIUM STEARATE  
    MANNITOL  
    POVIDONE  
    STEARIC ACID  
    SUCRALOSE  
    Product Characteristics
    Color PINK Score no score
    Shape ROUND Size 13mm
    Flavor BUBBLE GUM Imprint Code 44;447
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55910-447-01 1 in 1 CARTON
    1 30 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 02/03/2005
    Labeler - DOLGENCORP, LLC (068331990)
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