Label: CHEWABLE ACETAMINOPHEN CHILDRENS- acetaminophen tablet, chewable

  • NDC Code(s): 70000-0309-1
  • Packager: Cardinal Health 110, LLC. DBA Leader
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 18, 2023

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  • Active ingredient (in each chewable tablet)

    Acetaminophen 160 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    • temporarily relieves minor aches and pains due to:
      • headache
      • sore throat
      • flu
      • toothache
      • the common cold
    • temporarily reduces fever
  • 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 overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • 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 or crush tablets completely before swallowing; do not swallow tablets whole
    • 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 (chewable tablets)*
    Under 24Under 2Ask a doctor
    24-352-31 tablet
    36-474-51 1/2 tablets
    48-596-82 tablets
    60-719-102 1/2 tablets
    72-95113 tablets

    *or as directed by a doctor

  • Other information

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

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

  • Questions or comments?

    1-800-426-9391

  • Principal display panel

    LEADER™

    NDC 70000-0309-1

    Children's
    Chewable Acetaminophen
    160 mg Chewable Tablets | Pain Reliever / Fever Reducer

    Grape Flavor
    Ages 2 - 11
    Aspirin-Free
    Ibuprofen-Free
    Chew or crush tablets
    completely before swallowing.

    24 CHEWABLE TABLETS

    ACTUAL SIZE

    COMPARE TO
    CHILDREN'S TYLENOL®
    active ingredient**

    100% Money Back Guarantee

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

    100% Money Back Guarantee
    Return to place of purchase if not satisfied.

    CIN 5335326    REV. 9/22

    **This product is not manufactured or distributed by Johnson & Johnson
    Corporation, owner of the registered trademark Children’s Tylenol®.
    50844       REV0522B44908

    DISTRIBUTED BY CARDINAL HEALTH
    DUBLIN, OHIO 43017
    www.myleader.com
    1-800-200-6313

    ©2022 CARDINAL HEALTH, LEADER, and
    LOGOs are trademarks of Cardinal
    Health. All other marks are the property
    of their respective owners.

    Leader 44-449

    Leader 44-449

  • INGREDIENTS AND APPEARANCE
    CHEWABLE ACETAMINOPHEN  CHILDRENS
    acetaminophen tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0309
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
    ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorpurpleScore2 pieces
    ShapeROUNDSize16mm
    FlavorGRAPEImprint Code 44;449
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0309-11 in 1 CARTON01/28/2005
    124 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01301/28/2005
    Labeler - Cardinal Health 110, LLC. DBA Leader (063997360)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(70000-0309)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(70000-0309) , pack(70000-0309)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(70000-0309)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.117025878manufacture(70000-0309)
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