Label: ACETAMINOPHEN 500MG ES- acetaminophen 500mg tablet

  • NDC Code(s): 69168-011-24, 69168-011-40, 69168-011-50
  • Packager: Allegiant Health
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 8, 2019

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

  • Active Ingredient (in each tablet)

    Acetaminophen 500 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    temporary relief of minor aches and pains associated with

    • common cold
    • headache
    • toothache
    • muscular aches
    • backache
    • arthritis
    • menstrual cramps
    • temporarily reduces 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
    • 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 you have

    liver disease

    Ask a doctor or pharmacist before use if you 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
    • pain get worse or lasts more than 5 days in children under 12 years
    • 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

    If pregnant or breast-feeding

    ask a health professional before use.

    Keep out of reach of children

     In case of accidental overdose, contact a doctor or 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 tablets every 4 to 6 hours. Do not take more than 8 tablets in 24 hours.
    • Do not use more than 10 days unless directed by a doctor
    • children under 12 years of age: do not use this extra strength product; this will provide more than the recommended dose (overdose) and could cause serious health problems.
  • Other information

    • store between 20°-25°C (68°-77°F) 
    • do not use if imprinted safety seal under cap is broken or missing
  • Inactive ingredients

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

  • Principal Display Panel

    Pain Relief

    Pain Relief

    Pain Relief

    Pain Relief


  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 500MG  ES
    acetaminophen 500mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-011
    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)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Colorwhite (White) Scoreno score
    ShapeROUND (round) Size12mm
    FlavorImprint Code AZ;011
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-011-501 in 1 CARTON04/15/2016
    150 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:69168-011-401 in 1 CARTON04/15/2016
    240 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:69168-011-241 in 1 CARTON12/15/2021
    324 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01304/15/2016
    Labeler - Allegiant Health (079501930)