Label: ACETAMINOPHEN - acetaminophen tablet, chewable

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 June 6, 2012

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

  • Active Ingredient (in each chewable tablet)

    Acetaminophen 80 mg

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  • Purposes

    Pain Reliever/Fever Reducer

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  • Uses

    Temporarily relieves minor aches and pain due to:

    ■ The common cold  ■ Flu  ■ Headache  ■ 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 other drug containing acetaminophen (prescription or non prescription). 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 dose.

    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 the case of overdose, get medical help or contact a Poison Control Center right away. (1-800- 222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms.

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  • Directions

    This products does not contain directions or complete warnings for adult use.
    ■ Find right dose on the chart below. If possible, use weight to dose; otherwise, use age.
    ■ Chew before swallowing
    ■ If needed, repeat dose every 4 hours while symptoms lasts
    ■ Do not give more than 5 times in 24 hours
    ■ Do not give for more than 5 days unless directed by a doctor.


    Weight Age Tablets
    Under 24 lbs
    Under 2 years
    Ask a doctor
    24-35 lbs
    2-3 years
    2 tablets
    36-47 lbs
    4-5 years
    3 tablets
    48-59 lbs
    6-8 years
    4 tablets
    60-71 lbs
    9-10 years
    5 tablets
    72-95 lbs
    11 years
    6 tablets

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  • Other Information

    • Phenylketonurics: Contain Phenylalanine 14 mg per tablet
    • Do not use if imprinted safety seal under cap is broken or missing
    • Store at room temperature in a dry place
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  • Inactive Ingredients

    Aspartame, Colloidal Silica, D&C Red # 27 Lake, Hypromellose, Magnesium Stearate, Mannitol, Natural & Artificial Berry Flavors, Povidone, Pregelatinized Starch, Sodium Chloride, Sodium Starch Glycolate, Sorbitol, Stearic Acid and Sucralose.

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  • Questions?


    Adverse Drug Event Call: (800) 616-2471
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  • Principal Display Panel

    image of package label

    NDC 54868-5625-0

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

    Children's Chewable

    AGES 2-6

    Acetaminophen  Chewable Tablets

    30 Tablets, 80 mg EACH

    Fever reducer/ Pain reliever

    ASPIRIN FREE ● IBUPROFEN FREE


    See New Warnings Information
    Fruit Flavor
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  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-5625(NDC:0904-5256)
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 80 mg
    Inactive Ingredients
    Ingredient Name Strength
    ASPARTAME (UNII: Z0H242BBR1)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    SORBITOL (UNII: 506T60A25R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color pink Score no score
    Shape ROUND (ROUND BICONVEX TABLET) Size 10mm
    Flavor Imprint Code 1G
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54868-5625-0 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 final part343 06/29/2006
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    Name Address ID/FEI Business Operations
    Physicians Total Care, Inc. 194123980 relabel
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