IBU- ibu tablet 
DirectRX

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IBU

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

621-30

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)

Revised: 5/2019
Document Id: 87e796d8-8891-f1ac-e053-2995a90a85ad
Set id: 281fdc28-fe0f-3a47-e054-00144ff88e88
Version: 2
Effective Time: 20190502
 
DirectRX