IBU TABLET [DIRECTRX]

IBU TABLET [DIRECTRX]
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NDC 61919-621-90
Set ID 281fdc28-fe0f-3a47-e054-00144ff88e88
Category HUMAN PRESCRIPTION DRUG LABEL
Packager DirectRX
Generic Name
Product Class
Product Number
Application Number ANDA075682
  • BOXED WARNING (What is this?)

    Boxed Warning

    boxed warning

  • Description

  • Clinical Pharmacology

  • Indications and Usage

  • Contraindications

  • Warnings

  • Precautions

  • Adverse Reactions

  • Overdosage

  • Dosage and Administration

  • How Supplied

  • Medication Guide

  • Package Label

    label

  • PRINCIPAL DISPLAY PANEL

    621-30

  • INGREDIENTS AND APPEARANCE
    IBU 
    ibu tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61919-621(NDC:55111-684)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN800 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULESize9mm
    FlavorImprint Code 8I
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61919-621-9090 in 1 BOTTLE; Type 0: Not a Combination Product12/29/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07568212/29/2015
    Labeler - DirectRX (079254320)
    Registrant - DirectRX (079254320)
    Establishment
    NameAddressID/FEIBusiness Operations
    DirectRX079254320repack(61919-621)