Label: CHILDRENS PAIN RELIEF- acetaminophen tablet, chewable

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 29, 2023

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

  • Active ingredient (in each tablet)

    Acetaminophen USP 160 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses


    • temporarily relieves minor aches and pains due to:
      • the common cold
      • flu
      • headache
      • sore throat
      • toothache
    • 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.

    Overdose warning:Taking more than the recommended dose (overdose) may cause liver damage. In case of 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 (see overdose warning)
    • find 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

    Weight (lb)
    Age (yr)
    Dose (tablets)*
    * or as directed by a doctor
    under 24
    under 2 years
    ask a doctor
    24-35
    2-3 years
    1 tablet
    36-47
    4-5 years
    1½ tablets
    48-59
    6-8 years
    2 tablets
    60-71
    9-10 years
    2½ tablets
    72-95
    11 years
    3 tablets

  • Other information


    • store at 20° to 25°C (68° to 77°F). Avoid high humidity.
    • Tamper Evident: Do not use if carton is open or if printed seal on blister is broken or missing.
  • Inactive ingredients

    citric acid anhydrous, colloidal silicon dioxide, copovidone, crospovidone, D&C red No.27 lake, D&C red 30 aluminum lake, dextrose monohydrate, ethylcellulose, flavor, magnesium stearate, mannitol, sodium starch glycolate, stearic acid, sucralose.


    Questions or comments?

    Call 1-855-274-4122



    * This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Children's Tylenol ®Chewables.

    DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN



    Distributed by:
    AUROHEALTH LLC
    2572 Brunswick Pike
    Lawrenceville, NJ 08648

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 160 mg (24 Chewable Tablets)

    NDC 58602-766-76
    Ages 2-11
    Children's Pain Relief
    Acetaminophen 160 mg
    Pain reliever/Fever reducer

     

    • Aspirin Free                         
    • Ibuprofen Free

     


    Bubblegum Flavor

    Compare to the active ingredient in
    Children's Tylenol® Chewables*
    24
    Chewable Tablets



    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 160 mg (24 Chewable Tablets)

  • INGREDIENTS AND APPEARANCE
    CHILDRENS PAIN RELIEF 
    acetaminophen tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-766
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    COPOVIDONE K25-31 (UNII: D9C330MD8B)  
    CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
    ETHYLCELLULOSE (4 MPA.S) (UNII: KC5472WRJK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorpinkScore2 pieces
    ShapeROUNDSize16mm
    FlavorBUBBLE GUMImprint Code F8
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-766-764 in 1 CARTON09/13/2017
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01309/13/2017
    Labeler - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    APL HEALTHCARE LIMITED650844777manufacture(58602-766)