Label: CHILDRENS ACETAMINOPHEN- acetaminophen tablet, chewable

  • NDC Code(s): 64092-031-20
  • Packager: GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.
  • Category: HUMAN OTC DRUG LABEL

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 25, 2018

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active ingredient (in each tablet)

    Acetaminophen 80 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    • temporarily relieves minor aches and pains due to:
      • headache
      • the common cold
      • flu
      • toothache
      • sore throat
    • 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 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 24Under 2Ask a doctor
    24-352-32
    36-474-53
    48-596-84
    60-719-105
    72-95116

    *or as directed by a doctor

  • Other information

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

  • Questions or comments?

    Call 1-800-426-9391

  • Principal Display Panel

    HEALTHCARE

    NDC 64092-031-20

    Compare to the active ingredient in
    Children's Tylenol® Meltaways®

    Children's
    ACETAMINOPHEN

    Pain Reliever • Fever Reducer
    Aspirin Free • Ibuprofen Free

    Rapid Tabs

    Bubble Gum
    Flavor

    AGES 2-6

    20 Chewable Tablets 80 mg EACH

    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      REV0416E44709

    Distributed by:
    Great Lakes Wholesale & Marketing L.L.C.
    3729 Patterson Ave., S.E.
    Grand Rapids, MI 49512
    www.glwholesale.com

    HEALTHCARE GUARANTEE
    If you are not completely satisfied with this
    product, regardless of reason, return your unused
    portion to Great Lakes Wholesale for a full refund

    Healthcare 44-447

    Healthcare 44-447

  • INGREDIENTS AND APPEARANCE
    CHILDRENS ACETAMINOPHEN 
    acetaminophen tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64092-031
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN80 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorPINKScoreno score
    ShapeROUNDSize13mm
    FlavorBUBBLE GUMImprint Code 44;447
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64092-031-201 in 1 CARTON02/03/200511/28/2020
    120 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 FINALpart34302/03/200511/28/2020
    Labeler - GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. (361925498)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(64092-031)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(64092-031)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(64092-031)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(64092-031)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088PACK(64092-031)