Label: ACETAMINOPHEN tablet

  • 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 September 2, 2022

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

  • Drug Facts

    Active ingredient (in each chewable tablet)


    Acetaminophen USP 160 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    • temporarily relieves minor aches and pains due to:
      • the common cold
      • flu
      • headache
      • soar 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 or crush 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 lbs
    2 to 3 years
    1 tablet
    36 to 47 lbs
    4 to 5 years
    1½ tablets
    48 to 59 lbs
    6 to 8 years
    2 tablets
    60 to 71 lbs
    9 to 10 years
    2½ tablets
    72 to 95 lbs
    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: WALGREEN CO.
    200 WILMOT RD., DEERFIELD, IL 60015
    100% SATISFACTION GUARANTEED
    walgreens.com
    ©2021 Walgreen Co.
    MADE IN INDIA

    Code: TS/DRUGS/16/2014

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

    NDC 0363-9605-07

    Walgreens
    Compare to the active ingredient
    in Children's Tylenol® Chewables††

    Children's
    Pain & Fever
    ACETAMINOPHEN 160 mg
    PAIN RELIEVER / FEVER REDUCER

    Chewables
    Chew or crush tablets completely before swallowing
    Aspirin Free              Ibuprofen Free

    AGES
    2-11
    YEARS

    24 CHEWABLE TABLETS            ACTUAL SIZE                Bubble Gum flavor
    160 mg each

    DO NOT USE WITH OTHER MEDICINES
    CONTAINING ACETAMINOPHEN

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

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-9605
    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
    FlavorImprint Code F8
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-9605-074 in 1 CARTON07/05/2021
    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 FINALpart34307/05/2021
    Labeler - WALGREEN CO. (008965063)
    Registrant - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    APL HEALTHCARE LIMITED650844777MANUFACTURE(0363-9605)