Label: CHILDRENS PAIN RELIEF ACETAMINOPHEN- acetaminophen tablet, chewable 

  • Label RSS
  • 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 08/14

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
      • sore throat
      • 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 (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

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  • Directions

    • do not give more than directed (see overdose warning)
    • 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.
    • 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  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

    *or as directed by a doctor

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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
    • avoid high humidity
    • protect from light
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  • Inactive ingredients

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

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  • Questions or comments?

    1-800-426-9391

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  • Principal Display Panel

    RITE AID®
    PHARMACY

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

    children's pain relief
    acetaminophen

    acetaminophen 80 mg
    pain reliever • fever reducer

    for children ages 2-6
    aspirin and ibuprofen free

    30 CHEWABLE TABLETS

    grape flavored

    **This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Children's Tylenol® Meltaways®.                      50844      REV1013B45201

    DISTRIBUTED BY: RITE AID
    30 HUNTER LANE, CAMP HILL, PA 17011

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

    Rite-Aid-44-452

    Rite-Aid-44-452


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  • INGREDIENTS AND APPEARANCE
    CHILDRENS PAIN RELIEF ACETAMINOPHEN 
    acetaminophen tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11822-0452
    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  
    DEXTRATES  
    ETHYLCELLULOSES  
    FD&C BLUE NO. 1  
    MAGNESIUM STEARATE  
    MANNITOL  
    CROSPOVIDONE  
    STEARIC ACID  
    SUCRALOSE  
    Product Characteristics
    Color PURPLE Score no score
    Shape ROUND Size 13mm
    Flavor GRAPE Imprint Code 44;452
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11822-0452-1 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 12/06/2004
    Labeler - Rite Aid (014578892)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(11822-0452)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(11822-0452)
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