Raltegravir labels and packages

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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

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

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

  1. "ISENTRESS (RALTEGRAVIR) TABLET, FILM COATED ISENTRESS (RALTEGRAVIR) TABLET, CHEWABLE [MERCK SHARP & DOHME CORP.]".

Adapted from the FDA Package Insert.