Label: ACETAMINOPHEN tablet

  • NDC Code(s): 36800-665-10, 36800-665-21, 36800-665-40
  • Packager: TOPCO ASSOCIATES LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 18, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active ingredient (in each gelcap)

    Acetaminophen USP, 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

  • 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.
     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 pharmacist before use if you are

  • 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

    Drug Facts (continued)
    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. (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 gelcaps every 6 hours while symptoms last
     do not take more than 6 gelcaps 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 20°-25°C (68°-77°F)
     avoid high humidity
     see end panel for expiration date and lot number

  • Inactive ingredients

    ammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, n-butyl alcohol, polyethylene glycol, p ovidone k-30, pregelatinized starch, propylene glycol, red iron oxide, shellac glaze, stearic acid, titanium dioxide, yellow iron oxide

  • Questions or comments?

    call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

  • Principal Display Panel

    400ct100ct225ct

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-665
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SHELLAC (UNII: 46N107B71O)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    AMMONIA (UNII: 5138Q19F1X)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POVIDONE K30 (UNII: U725QWY32X)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Product Characteristics
    Colorgray (Encapsulated with red opaque and blue gray opaque hard gelatin shells) Score2 pieces
    ShapeOVALSize19mm
    FlavorImprint Code G1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-665-21225 in 1 BOTTLE; Type 0: Not a Combination Product10/14/2024
    2NDC:36800-665-10100 in 1 BOTTLE; Type 0: Not a Combination Product10/14/2024
    3NDC:36800-665-40400 in 1 BOTTLE; Type 0: Not a Combination Product10/14/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01310/14/2024
    Labeler - TOPCO ASSOCIATES LLC (006935977)