Label: ACETAMINOPHEN CAPLET- acetaminophen tablet

  • NDC Code(s): 62207-177-81, 62207-177-85
  • Packager: Granules India Limited
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated February 22, 2024

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  • Acetaminophen Tablets 500 mg (Caplet)

    1-62207-177-85

    2-62207-177-85

    62207-177-85

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN  CAPLET
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-177
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    Product Characteristics
    Colorwhite (White to Off-white) Scoreno score
    ShapeCAPSULE (Caplet Shape) Size17mm
    FlavorImprint Code G551
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62207-177-81144144 in 1 BOX; Type 0: Not a Combination Product12/29/2017
    2NDC:62207-177-8590000 in 1 BOX; Type 0: Not a Combination Product06/14/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only12/29/2017
    Labeler - Granules India Limited (915000087)
    Registrant - Granules India Limited (915000087)
    Establishment
    NameAddressID/FEIBusiness Operations
    Granules India Limited918609236manufacture(62207-177) , pack(62207-177) , label(62207-177) , analysis(62207-177)
    Establishment
    NameAddressID/FEIBusiness Operations
    GRANULES LIFE SCIENCES PRIVATE LIMITED644776835analysis(62207-177) , manufacture(62207-177) , pack(62207-177) , label(62207-177)