Product Label :Medicines Approved in U.S. After June 2006

Highlights of Prescribing Information:

• Product Names, Other Required Information
• Boxed Warning
• Recent Major Changes
• Indications and Usage
• Dosage and Administration
• Dosage Forms and Strengths
• Contraindications
• Warnings and Precautions
• Adverse Reactions
• Drug Interactions
• Use in Specific Populations

Full Prescribing Information:

Boxed Warning (if required)
1. Indications and Usage
2. Dosage and Administration
3. Dosage Forms and Strengths
4. Contraindications
5. Warnings and Precautions
6. Adverse Reactions
7. Drug Interactions
8. Use in Specific Populations
− 8.1 Pregnancy
− 8.2 Labor and delivery
− 8.3 Nursing mothers
− 8.4 Pediatric use
− 8.5 Geriatric use
9. Medicine Abuse and Dependence
− 9.1 Controlled substance
− 9.2 Abuse
− 9.3 Dependence
10. Overdosage
11. Description
12. Clinical Pharmacology
− 12.1 Mechanism of action
− 12.2 Pharmacodynamics
− 12.3 Pharmacokinetics
13. Nonclinical Toxicology
− 13.1 Carcinogenesis, mutagenesis, impairment of fertility
− 13.2 Animal toxicology and/or pharmacology
14. Clinical Studies
15. References
16. How Supplied/Storage and Handling
17. Patient Counseling Information