Label: ACETAMINOPHEN 500MG tablet

  • NDC Code(s): 70692-117-06, 70692-117-41
  • Packager: Strive Pharmaceuticals Inc
  • 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 November 16, 2020

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

  • ACTIVE INGREDIENT

    Acetaminophen 500mg

  • INACTIVE INGREDIENT

    colloidal silicon dioxide, gelatin, glycerin, hydroxypropyl methyl cellulose, maize starch, magnesium stearate, purified talc, sodium starch glycolate

  • DOSAGE & ADMINISTRATION

    • take with a full glass of water
    • do not take more than directed
    adults and children 12 years of age and over
    • take 2 caplets every 6 hours while symptoms last
    • do not take more than 6 caplets in 24 hours, unless directed by a doctor
    • do not use for more than 10 days unless directed by a doctor
    children under 12 years of age ask a doctor

  • INDICATIONS & USAGE

    *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 4000mg 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

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

    Ask a doctor before use if you have

    • liver disease

    Ask a doctor or a pharmacist 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
    • fever gets worse or lasts more than 3 days
    • new symptoms occur
    • redness or swelling is present

    These could be signs of a serious comdition

    If pregnant or breast-feeding,

    ask a health professional before use

    Keep out of reach of children

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    Overdose Warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • PURPOSE

    Pain reliever / Fever reducer

  • OTHER SAFETY INFORMATION

    • store at room temperature between 20 ºC - 25 ºC (68 ºF - 77 ºF)
  • PRINCIPAL DISPLAY PANEL

    LB11706CT11706CT11741

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 500MG 
    acetaminophen 500mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70692-117
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULESize18mm
    FlavorImprint Code A5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70692-117-414 in 1 PACKAGE; Type 0: Not a Combination Product12/20/2018
    2NDC:70692-117-0660 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34312/20/2018
    Labeler - Strive Pharmaceuticals Inc (080028013)