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 January 10, 2020

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  • DRUG FACTS:

  • Active ingredient (in each caplet)

    Acetaminophen 500 mg

    Purpose

    Pain reliever/fever reducer

  • Inactive Ingredients:

    Corn Starch, Magnesium Stearate, Sodium Starch Glycolate, PVP.

  • USES:

    • Temporarily relieves minor aches and pains due to
    • headache
    • the common cold
    • muscular aches
    • backache
    • toothache
    • premenstrual and menstrual cramps
    • minor pain of arthritis
    • 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 a 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:

    • with any other drug containing acetaminophen - if you are not sure whether a drug contains acetaminophen - ask a doctor or pharmacist
    • for more than 10 days for pains unless directed by a doctor
    • for more than 3 days for fever unless directed by a doctor
    • if you have ever had an allergic reaction to this product or any of its ingredients.

    Ask a doctor before use if you have:

    • liver disease.

    Ask a doctor before use if 

    you are taking the blood thinning drug warfarin.

    Stop use and ask a doctor if

    • pain gets worse or lasts more than 10 days
    • ever gets worse or lasts more than 3 days
    • redness or swelling is present. These could be signs of a serious condition.

    If pregnant or breast-feeding:

    Ask a health professional before use.

    KEEP OUT OF REACH OF CHILDREN.

    Overdose warning. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not noti ce any signs or symptoms.

  • DIRECTIONS:

    do not take 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 6 caplets in 24 hours.
    • do not take more than 10 days unless directed by a doctor.

    Children under 12 years: ask a doctor.

  • OTHER INFORMATION:

    Store at 20 - 25°C (68 - 77°F).

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69477-000
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize20mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69477-000-01200 in 1 BOTTLE; Type 0: Not a Combination Product11/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34311/01/2018
    Labeler - Global Pharm Distribution LLC (052115351)
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