Label: CHILDRENS PAIN AND FEVER- 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 December 10, 2019

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

  • 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 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
    • 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 24
    Under 2Ask a doctor
    24-352-31 tablet
    36-474-51 1/2 tablet
    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, flavor, magnesium stearate, mannitol, polyethylene, stearic acid, sucralose

  • Questions or comments?

    1-888-423-0139

  • Principal display panel

    +TopCare®
    health™

    NDC 36800-450-08

    COMPARE TO CHILDREN’S
    TYLENOL® ACTIVE INGREDIENT

    children's 
    Pain & Fever

    ACETAMINOPHEN 160 mg, CHEWABLE TABLETS
    PAIN RELIEVER  •  FEVER REDUCER

    • Ibuprofen Free   • Aspirin Free

    Chew or crush tablets completely before swallowing.

    BUBBLE
    GUM
    FLAVOR

    24 CHEWABLE TABLETS

    For Ages 2 to 11 Years

    actual size

    OUR PHARMACISTS RECOMMEND

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


    QUALITY GUARANTEED

    This product is not manufactured or distributed by Johnson &
    Johnson Corporation, owner of the registered trademark Children’s
    Tylenol®.         50844      ORG101845008

    DISTRIBUTED BY TOPCO ASSOCIATES LLC
    ELK GROVE VILLAGE, IL 60007 ©TOPCO LNKA1118
    QUESTIONS? 1-888-423-0139
    topcare@topco.com www.topcarebrand.com

    Topcare 44-450

    Topcare 44-450

  • INGREDIENTS AND APPEARANCE
    CHILDRENS PAIN AND FEVER 
    acetaminophen tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-450
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSPOVIDONE, UNSPECIFIED (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)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    Product Characteristics
    ColorPINKScore2 pieces
    ShapeROUNDSize16mm
    FlavorBUBBLE GUMImprint Code 44;450
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-450-081 in 1 CARTON02/15/2019
    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 FINALpart34302/15/2019
    Labeler - Topco Associates, LLC (006935977)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(36800-450)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(36800-450)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088PACK(36800-450)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(36800-450)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(36800-450)