Label: ACETAMINOPHEN 500MG ES- acetaminophen 500mg tablet

  • NDC Code(s): 69168-011-40, 69168-011-50
  • Packager: Allegiant Health
  • 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 January 8, 2019

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  • Active Ingredient (in each tablet)

    Acteminophen 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

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

    Keep out of reach of children

    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

    Acetaminophen 500mg

    Acetaminophen 500mg


  • 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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34304/15/2016
    Labeler - Allegiant Health (079501930)
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