Label: CHILDRENS PAIN RELIEF- 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 11, 2020

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  • 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, FD &C Blue No.1 lake, 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: Discount Drug Mart
    211 Commerce Drive
    Medina, OH 44256
    www.discount-drugmart.com    

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

    NDC 53943-836-76

    *Compare to the active ingredient
    in Children's Tylenol® Chewables
    Ages 2-11
    Children's Pain Relief
    Acetaminophen 160 mg
    Pain reliever/Fever reducer
     

    • Aspirin Free                         
    • Ibuprofen Free

     
    Grape Flavor

    24
    Chewable Tablets

    figure 1

  • INGREDIENTS AND APPEARANCE
    CHILDRENS PAIN RELIEF 
    acetaminophen tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53943-836
    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)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorPURPLEScore2 pieces
    ShapeROUNDSize16mm
    FlavorGRAPEImprint Code J26
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53943-836-764 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 NOT FINALpart34309/13/2017
    Labeler - DISCOUNT DRUG MART (047741335)
    Registrant - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    APL HEALTHCARE LIMITED650844777MANUFACTURE(53943-836)
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