Label: CHILDRENS CHEWABLE ACETAMINOPHEN- 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 3, 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 2

    Ask a doctor

    24-35

    2-3

    1 tablet

    36-47

    4-5

    1 1/2 tablets

    48-59

    6-8

    2 tablets

    60-71

    9-10

    2 1/2 tablets

    72-95

    11

    3 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

    NDC 53943-449-08

    Discount
    Drug
    Mart
    Food Fair

    Ages 2-11

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

    Aspirin Free
    Ibuprofen Free

    Actual Size

    Grape Flavor

    †Compare to the active ingredient of CHILDREN'S TYLENOL®

    24 CHEWABLE TABLETS
    Chew or crush tablets completely before swallowing.

    †This product is not manufactured or distributed
    by Johnson & Johnson Corporation, owner of the
    registered trademark Children’s Tylenol®.
    50844 ORG101844908

    DISTRIBUTED BY: DRUG MART - FOOD FAIR
    211 COMMERCE DRIVE, MEDINA, OH 44256
    www.discount-drugmart.com

    SATISFACTION GUARANTEED
    IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE
    TO STORE WHERE PURCHASED. IF UNABLE TO RETURN TO
    STORE, SEND REASON FOR DISSATISFACTION, NAME,
    ADDRESS AND EMPTY PACKAGE TO:
    DISCOUNT DRUG MART
    211 COMMERCE DRIVE, MEDINA, OHIO 44256

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

    Drug Mart 44-449

    Drug Mart 44-449

  • INGREDIENTS AND APPEARANCE
    CHILDRENS CHEWABLE ACETAMINOPHEN 
    acetaminophen tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53943-449
    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 ACETATE (UNII: DSO12WL7AU)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    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:53943-449-081 in 1 CARTON01/13/2020
    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 FINALpart34301/13/2020
    Labeler - Discount Drug Mart (047741335)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(53943-449)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(53943-449)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088PACK(53943-449)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(53943-449)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(53943-449)