Label: CHILDRENS CHEWABLE- acetaminophen tablet, chewable

  • 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 November 9, 2021

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  • Active ingredient (in each 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 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.

  • Directions

    • this product does not contain directions or complete warnings for adult use
    • do not give more than directed
    • 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
    • find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
    Weight (lb)Age (yr)Dose (tablets)*
    Under 24Under 2
    		Ask a doctor
    24-352-3
    		1
    36-474-5
    		1 1/2
    48-596-82
    60-719-102 1/2
     72-95113

    *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, flavor, magnesium stearate, mannitol, polyethylene, stearic acid, sucralose

  • Questions or comments?

    1-800-426-9391

  • Principal display panel

    COREVALUES™

    Compare to active ingredient in
    Children’s Tylenol®†

    Ages 2-11

    Children’s Chewable
    Acetaminophen 160 mg

    Pain Reliever/Fever Reducer
    aspirin & ibuprofen free

    24 chewable tablets

    Actual Size
    bubblegum flavor

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

    †This product is not manufactured or
    distributed by Johnson & Johnson
    Corporation, owner of the registered
    trademark Children’s Tylenol®.
    50844      ORG021745008

    Distributed by: Liberty Procurement Co. Inc.
    650 Liberty Ave., Union, NJ 07083 U.S.A.
    Satisfaction Guaranteed Or Your Money Back
    Visit us at www.facevalues.com

    Core Values 44-450

    Core Values 44-450

  • INGREDIENTS AND APPEARANCE
    CHILDRENS CHEWABLE 
    acetaminophen tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-450
    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 (UNII: 2S7830E561)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
    Product Characteristics
    ColorpinkScore2 pieces
    ShapeROUNDSize16mm
    FlavorBUBBLE GUMImprint Code 44;450
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63940-450-081 in 1 CARTON02/25/200507/09/2023
    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 not finalpart34302/25/200507/09/2023
    Labeler - Harmon Store Inc. (804085293)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(63940-450)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(63940-450)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(63940-450)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(63940-450)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088pack(63940-450)
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