IBU by DirectRX IBU tablet

IBU by

Drug Labeling and Warnings

IBU by is a Prescription medication manufactured, distributed, or labeled by DirectRX. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Description

Clinical Pharmacology

Indications and Usage

Contraindications

Warnings

Precautions

Adverse Reactions

Overdosage

Dosage and Administration

How Supplied

Medication Guide

Package Label

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

IBU 
ibu tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 61919-621(NDC:55111-684)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	800 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score	no score
Shape	CAPSULE	Size	9mm
Flavor		Imprint Code	8I
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61919-621-90	90 in 1 BOTTLE; Type 0: Not a Combination Product	12/29/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075682	12/29/2015

Labeler - DirectRX (079254320)

Registrant - DirectRX (079254320)

Establishment
Name	Address	ID/FEI	Business Operations
DirectRX		079254320	repack(61919-621)