SOLU-MEDROL (Page 6 of 6)

STORAGE CONDITIONS

Protect from light.

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

Store reconstituted solution (not further diluted) at controlled room temperature 20° to 25°C (68° to 77°F) [see USP], and use it within 48 hours.

See section DOSAGE AND ADMINISTRATION, for storage of further diluted solution.

HOW SUPPLIED

SOLU-MEDROL Sterile Powder preserved with benzyl alcohol is available in the following packages:

500 mg (Multi-Dose Vial) 8 mL NDC 0009-0758-01 2 gram Vial (Single-Dose Vial) NDC 0009-0850-01

1 gram (Multi-Dose Vial) 16 mL NDC 0009-0698-01 2 gram Vial with Diluent (Single-Dose Vial) NDC 0009-0796-01

SOLU-MEDROL Sterile Powder preservative-free is available in the following packages:

40 mg Act-O-Vial System (Single-Dose Vial) 25 ×1 mL NDC 0009-0039-28 125 mg Act-O-Vial System (Single-Dose Vial) 25 × 2 mL NDC 0009-0047-22 500 mg Act-O-Vial System (Single-Dose Vial) 4 mL NDC 0009-0003-02

1 gram Act-O-Vial System (Single-Dose Vial) 8 mL NDC 0009-0018-20

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

LAB-0161-18.0
Revised: October 2021

PRINCIPAL DISPLAY PANEL — VIAL LABEL

1 mL Act-O-Vial ^®

Solu-Medrol ^®
(methylprednisolone sodium
succinate for injection, USP)

40 mg* per vial

Preservative-Free Rx only

PRINCIPAL DISPLAY PANEL — OUTER PACKAGE

NDC 71872-7085-1

Single-Dose Vial.
Discard unused portion.
1 x 1 mL Act-O-Vial ^® System

Solu-Medrol ^®
(methylprednisolone sodium
succinate for injection, USP)

40 mg* per vial

For Intramuscular or Intravenous Use Only

Preservative-Free

Rx only

SOLU-MEDROL methylprednisolone sodium succinate injection, powder, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71872-7085(NDC:0009-0039) Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYLPREDNISOLONE SODIUM SUCCINATE (METHYLPREDNISOLONE) METHYLPREDNISOLONE 40 mg in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS 1.6 mg in 1 mL SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM 17.46 mg in 1 mL LACTOSE MONOHYDRATE 25 mg in 1 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:71872-7085-1 1 VIAL in 1 BAG contains a VIAL 1 1 mL in 1 VIAL This package is contained within the BAG (71872-7085-1)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA011856 04/02/1959

Labeler — Medical Purchasing Solutions, LLC (601458529)

Establishment
Name	Address	ID/FEI	Operations
Medical Purchasing Solutions, LLC		601458529	repack (71872-7085)

Revised: 04/2022 Medical Purchasing Solutions, LLC