Label: ACETAMINOPHEN tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated July 20, 2020

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

  • Acetaminophen Tablets 500 mg

    acetaminophen-500mg-100 ct-jpg

    acetaminophen-500mg-200 ct-jpg

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79583-001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    TALC (UNII: 7SEV7J4R1U)  
    POVIDONE K30 (UNII: U725QWY32X)  
    Product Characteristics
    Colorwhite (White to Off-white) Scoreno score
    ShapeCAPSULE (Caplet Shape) Size18mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79583-001-01100 in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
    2NDC:79583-001-02200 in 1 BOTTLE; Type 0: Not a Combination Product07/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only07/20/2020
    Labeler - Rescuers Life sciences Limited (860239707)