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 April 18, 2022

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  • Active ingredient (in each tablet)

    Acetaminophen 500mg

  • PURPOSE

    Pain reliever/fever reducer

  • USES

    temporarily relieves minor aches and pains due to:  

    • the common cold  
    • headache  
    • backache  
    • minor pain of arthritis
    • toothache  
    • muscular aches  
    • premenstrual and menstrual cramps
    • temporarily reduces fever
  • WARNINGS

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

    • more than 4,000mg of acetaminophen in 24 hours  
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    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.

    Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

    Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • DO NOT USE

    Do not use  

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether drug contains acetaminophen, ask a doctor or pharmacist.  
    • if you are allergic to acetaminophen or any of the inactive ingredients in this product
  • ASK DOCTOR

    Ask a doctor before use if you have liver disease

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

  • STOP USE

    Stop use and ask a doctor if  

    • pain gets worse or lasts more than 10 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
    • You may report side effects to 1-888-952-0050
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Directions

    do not take more than directed (see overdose warning)

    Adults and children 12 years and over

    • take 2 tablets every 6 hours while symptoms last
    • do not take more than 8 tablets in 24 hours, unless directed by a doctor
    • do not take for more than 10 days unless directed by a doctor

    Children under 12 years of age

    • ask a doctor
  • Other information

    store between 20º-25ºC (68º-77ºF)

  • INACTIVE INGREDIENT

    corn starch, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

  • PRINCIPAL DISPLAY PANEL

    labellabel2

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73659-013
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScorescore with uneven pieces
    ShapeROUNDSize12mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73659-013-0150 in 1 BOX04/18/2022
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:73659-013-02125 in 1 BOX04/18/2022
    22 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34304/18/2022
    Labeler - Rapid Care, Inc (877432778)
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