Label: ACETAMINOPHEN CAPLETS, 500 MG EXTRA STRENGTH- acetaminophen tablet

  • NDC Code(s): 70795-1200-1, 70795-1200-2
  • Packager: GRAXCELL PHARMACEUTICAL, LLC
  • 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 December 15, 2020

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

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

  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

    • more than 4,000 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:

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • you have ever had an allergic reaction to this productor any of its ingredients

    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

    • 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 condition.

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

    Do not use

    without consulting a physician

    Ask a physician before use

     if you have a sodium restricted diet due to multiple organ diseases

    Stop use and ask a physician

    If symptoms of heat cramps continue for more than 24 hours

    If pregnant or breast-feeding

    ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)  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 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, unless directed by a doctor
    • do not use for more than 10 days unless directed by a doctor

    Children under 12 years

    • ask a doctor

  • Other information

    • Store at room temperature 20°-25°C (68°-77°F).
  • INACTIVE INGREDIENTS

    carnauba wax, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Acetominaphen_500mg_front

    01b LBL_Acetominaphen_500mg_back

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN CAPLETS, 500 MG  EXTRA STRENGTH
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70795-1200
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    HYPROMELLOSE 2208 (100000 MPA.S) (UNII: VM7F0B23ZI)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize18mm
    FlavorImprint Code 500
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70795-1200-1100 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2020
    2NDC:70795-1200-2200 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34311/16/2020
    Labeler - GRAXCELL PHARMACEUTICAL, LLC (056556923)