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Raltegravir labels and packages

Introduction

Raltegravir
Isentress® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Overdosage
Dosage and Administration
How Supplied
Labels and Packages
Labels and Packages

Labels and Packages

PRINCIPAL DISPLAY PANEL – 400 mg Bottle Label

NDC 0006-0227-61

Isentress® (raltegravir) tablets

400 mg

Each tablet contains 434.4 mg raltegravir potassium, equivalent to 400 mg raltegravir.

USUAL DOSAGE: See Package Insert.

Rx only

60 Tablets

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PRINCIPAL DISPLAY PANEL – 100 mg Bottle Label

NDC 0006-0477-61

Isentress® (raltegravir) CHEWABLE Tablets

100 mg

For Pediatric Patients 2 to less than 12 Years of Age

Phenylketonurics: contains phenylalanine (a component of aspartame) 0.10 mg per 100 mg chewable tablet.

Rx only

60 Tablets

[[File:|800px|thumb]]

PRINCIPAL DISPLAY PANEL – 25 mg Bottle Label

NDC 0006-0473-61

Isentress® (raltegravir) CHEWABLE Tablets

25 mg

For Pediatric Patients 2 to less than 12 Years of Age

Phenylketonurics: contains phenylalanine (a component of aspartame) 0.05 mg per 25 mg chewable tablet.

Rx only

60 Tablets[1]

[[File:|800px|thumb]]
References

References

Adapted from the FDA Package Insert.

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]