Label: ACETAMINOPHEN CHILDRENS- acetaminophen tablet, chewable

  • NDC Code(s): 55301-447-01
  • Packager: ARMY AND AIR FORCE EXCHANGE SERVICE
  • 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 29, 2018

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:
      • headache
      • the common cold
      • flu
      • toothache
      • sore throat
    • 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

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

    If a skin reaction occurs, stop use and seek medical help right away.

    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.

    In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children 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
    •  do not give more than directed
    • 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

    • avoid high humidity
    • store at 25°C (77°F); 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, dextrates hydrated, ethylcellulose, 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

    exchange✓select™

    Compare To The Active Ingredient
    of Children’s Tylenol® Meltaways®

    Ibuprofen Free • Aspirin Free
    AGES 2-6

    Children's
    Acetaminophen

    Pain Reliever/Fever Reducer
    BUBBLEGUM FLAVOR

    Actual Size

    30 Rapid Tablets 80mg each

    ✓ quality value

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED
    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®.      50844     REV0416G44701

    "SATISFACTION GUARANTEED OR YOUR MONEY BACK"
    Manufactured For Your Military Exchanges
    Distributed by: LNK International, Inc.
    Hauppauge, NY 11788
    1-800-426-9391

    Exchange Select 44-447

    Exchange Select 44-447

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  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN  CHILDRENS
    acetaminophen tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55301-447
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
    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:55301-447-01 1 in 1 CARTON 02/03/2005 11/28/2020
    1 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 02/03/2005 11/28/2020
    Labeler - ARMY AND AIR FORCE EXCHANGE SERVICE (001695568)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(55301-447)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(55301-447)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867837 PACK(55301-447)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 967626305 PACK(55301-447)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 868734088 PACK(55301-447)
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