Label: CHILDRENS PAIN RELIEF- acetaminophen tablet, chewable

  • NDC Code(s): 21130-223-76
  • Packager: Better Living Brands, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 28, 2023

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

  • Drug Facts

    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 dose (see overdose warning)

  • 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:In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
    Quick 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)
    • chew tablets completely before swallowing; do not swallow tablets whole
    • find right dose on chart below. If possible, use weight to dose; otherwise, use age
    • repeat dose every 4 hours while symptoms last
    • do not give more than 5 times in 24 hours
    Weight (lb)
    Age (yr)
    Dose (tablets)*
    under 24
    under 2 years
    ask a doctor
    24 to 35
    2 to 3 years
    1 tablet
    36 to 47
    4 to 5 years
    1½ tablets
    48 to 59
    6 to 8 years
    2 tablets
    60 to 71
    9 to 10 years
    2½ tablets
    72 to 95
    11 years
    3 tablets

    *or as directed by a doctor

  • Other information

    • store between 20° to 25°C (68° to 77°F). Avoid high humidity. Protect from light.
    • 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

    DISTRIBUTED BY:

    BETTER LIVING BRANDS LLC
    P.O.BOX 99 PLEASANTON,
    CA 94566-0009
    1-888-723-3929

    Made in India

    Code: TS/DRUGS/16/2014


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

    Signature
    care ®
    Quality
    Guaranteed

    Compare to the
    Children's Tylenol ®
    Chewables
    active ingredient **

    NDC 21130-223-76

    AGES 2-11
    DO NOT USE WITH OTHER MEDICINES
    CONTAINING ACETAMINOPHEN

    Childrens’s
    Pain Relief
    Acetaminophen Chewable Tablets 160 mg

    Pain Reliever/Fever Reducer

    • Aspirin Free              
    • Ibuprofen Free

    BUBBLE GUM
    Flavor

    Actual Size

    24 CHEWABLE TABLETS
    160 mg each




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

  • INGREDIENTS AND APPEARANCE
    CHILDRENS PAIN RELIEF 
    acetaminophen tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-223
    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:21130-223-764 in 1 CARTON11/15/2023
    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 DrugM01311/15/2023
    Labeler - Better Living Brands, LLC (009137209)
    Registrant - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    APL HEALTHCARE LIMITED650844777manufacture(21130-223)