IBU

IBU- ibuprofen tablet
DirectRX

Description

Clinical Pharmacology

Indications and Usage

Contraindications

Warnings

Precautions

Adverse Reactions

Overdosage

Dosage and Administration

How Supplied

Medication Guide

Package Label

label
(click image for full-size original)

621-30
(click image for full-size original)

IBU
ibu tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61919-621(NDC:55111-684)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IBUPROFEN (IBUPROFEN) IBUPROFEN 800 mg
Inactive Ingredients
Ingredient Name Strength
POLYSORBATE 80
POLYETHYLENE GLYCOL, UNSPECIFIED
TITANIUM DIOXIDE
CARNAUBA WAX
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYDEXTROSE
Product Characteristics
Color white Score no score
Shape CAPSULE Size 9mm
Flavor Imprint Code 8I
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61919-621-90 90 TABLET in 1 BOTTLE None
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 Operations
DirectRX 079254320 repack (61919-621)

Revised: 05/2019 DirectRX

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