SOLU-CORTEF® How Supplied/Storage and Handling

(hydrocortisone sodium succinate)

HOW SUPPLIED

SOLU-CORTEF Sterile Powder is available in the following packages:

100 mg Plain—NDC 0009-0825-01

100 mg ACT-O-VIAL (Single-Dose Vial)

250 mg ACT-O-VIAL (Single-Dose Vial)

         2 mL—NDC 0009-0011-03

         2 mL—NDC 0009-0013-05

25 × 2 mL—NDC 0009-0011-04

25 × 2 mL—NDC 0009-0013-06

500 mg ACT-O-VIAL (Single-Dose Vial)—NDC 0009-0016-12

1000 mg ACT-O-VIAL (Single-Dose Vial)—NDC 0009-0005-01

STORAGE CONDITIONS

Store unreconstituted product at controlled room temperature 20° to 25°C (68° to 77°F).

Store solution at controlled room temperature 20° to 25°C (68° to 77°F) and protect from light. Use solution only if it is clear. Unused solution should be discarded after 3 days.

This product's label may have been updated. For current full prescribing information please visit www.pfizer.com

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Health Professional Information

How Supplied/Storage and Handling

HOW SUPPLIED

SOLU-CORTEF Sterile Powder is available in the following packages:

100 mg Plain—NDC 0009-0825-01

100 mg ACT-O-VIAL (Single-Dose Vial)

250 mg ACT-O-VIAL (Single-Dose Vial)

         2 mL—NDC 0009-0011-03

         2 mL—NDC 0009-0013-05

25 × 2 mL—NDC 0009-0011-04

25 × 2 mL—NDC 0009-0013-06

500 mg ACT-O-VIAL (Single-Dose Vial)—NDC 0009-0016-12

1000 mg ACT-O-VIAL (Single-Dose Vial)—NDC 0009-0005-01

STORAGE CONDITIONS

Store unreconstituted product at controlled room temperature 20° to 25°C (68° to 77°F).

Store solution at controlled room temperature 20° to 25°C (68° to 77°F) and protect from light. Use solution only if it is clear. Unused solution should be discarded after 3 days.

This product's label may have been updated. For current full prescribing information please visit www.pfizer.com

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Pfizer Safety Reporting Site

*If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site.

If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or call (800) 822-7967.