Label: PAIN RELIEF EXTRA STRENGTH- acetaminophen 500 mg tablet

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

Drug Label Information

Updated April 28, 2021

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  • Active ingredient(s)

    Acetaminophen 500 mg

  • Purpose

    Pain reliever/fever reducer

  • Use(s)

    temporary relief of minor aches and pains associated with   ■ common cold   ■ headache    ■  toothache   ■ muscular aches   ■ backache     ■ arthritis    ■ menstrual cramps    ■ and reduction of fever

  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4000 mg of acetaminophen in 24 hours, which is the maximum daily amount 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

    Do not use

    • if you are allergic to acetaminophen  
    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

    Ask a doctor before use if

    liver disease

    Ask a doctor or pharmacist before use if

    are taking the blood thinning drug warfarin

    Stop use and ask a doctor if

    • symptoms do not improve pain gets worse or lasts for more than 10 days 
    • fever gets worse or lasts for more than 3 days new symptoms occur redness or swelling is present 
    • a rare sensitivity reaction occurs   
    • You may report side effects to 1-888-952-0050

    Pregnancy/Breastfeeding

    ask a health professional before use.

    Keep out of reach of children

    In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
    Do not exceed recommended dosage.

    Overdose Warning

     Overdose Warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get 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.

  • Directions

    ■ do not use more than directed (see overdose warning)  

    ■ adults and children 12 years and over:  take 2 caplets every 6 hours while symptoms last ■ do not take more than 8 caplets 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: ask a doctor 

  • Other information

      ■ do not use if imprinted safety seal under cap is broken or missing

  • Storage

    ■ store between 20º-25ºC (68º-77ºF)

  • Inactive ingredients

    corn starch, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

  • Principal Display Panel

    Pain Relief

    Pain Relief


  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF  EXTRA STRENGTH
    acetaminophen 500 mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50804-328
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code AZ328
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50804-328-011 in 1 CARTON04/28/2021
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01312/17/2014
    Labeler - Good Sense (076059836)
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