RISPERDAL CONSTA: Package Insert and Label Information (Page 8 of 8)

PRINCIPAL DISPLAY PANEL — 25 mg Kit Carton

25 mg Dose Pack

Store Package
in Refrigerator
(see bottom panel for
storage conditions)

Rx only
Single use only

NDC 50458-306-11

RisperdalCONSTA ^®
risperiDONE Long-Acting Injection

DOSE PACK CONTENTS:

• One 25 mg vial of risperidone extended-release microspheres for injection
• One pre-filled syringe containing 2 mL of diluent
• One Vial Adapter
• One 21-gauge UTW 1″ Terumo SurGuard^® 3 safety needle for deltoid injection
• One 20-gauge TW 2″ Terumo SurGuard^® 3 safety needle for gluteal injection

Do not substitute any components of the dose pack.

For deltoid or gluteal intramuscular injection only Each injection should be administered by a healthcare professional.

PLEASE READ COMPLETE INSTRUCTIONS PRIOR TO USE.

PRINCIPAL DISPLAY PANEL — 37.5 mg Kit Carton

37.5 mg Dose Pack

Store Package
in Refrigerator
(see bottom panel for
storage conditions)

Rx only
Single use only

NDC 50458-307-11

RisperdalCONSTA ^®
risperiDONE Long-Acting Injection

DOSE PACK CONTENTS:

• One 37.5 mg vial of risperidone extended-release microspheres for injection
• One pre-filled syringe containing 2 mL of diluent
• One Vial Adapter
• One 21-gauge UTW 1″ Terumo SurGuard^® 3 safety needle for deltoid injection
• One 20-gauge TW 2″ Terumo SurGuard^® 3 safety needle for gluteal injection

Do not substitute any components of the dose pack.

For deltoid or gluteal intramuscular injection only Each injection should be administered by a healthcare professional.

PLEASE READ COMPLETE INSTRUCTIONS PRIOR TO USE.

PRINCIPAL DISPLAY PANEL — 50 mg Kit Carton

50 mg Dose Pack

Store Package
in Refrigerator
(see bottom panel for
storage conditions)

Rx only
Single use only

NDC 50458-308-11

RisperdalCONSTA ^®
risperiDONE Long-Acting Injection

DOSE PACK CONTENTS:

• One 50 mg vial of risperidone extended-release microspheres for injection
• One pre-filled syringe containing 2 mL of diluent
• One Vial Adapter
• One 21-gauge UTW 1″ Terumo SurGuard^® 3 safety needle for deltoid injection
• One 20-gauge TW 2″ Terumo SurGuard^® 3 safety needle for gluteal injection

Do not substitute any components of the dose pack.

For deltoid or gluteal intramuscular injection only Each injection should be administered by a healthcare professional.

PLEASE READ COMPLETE INSTRUCTIONS PRIOR TO USE.

RISPERDAL CONSTA risperidone kit

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50458-309

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:50458-309-11 1 KIT in 1 BOX None

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 VIAL 2 mL Part 2 1 SYRINGE 2 mL

Part 1 of 2 RISPERDAL CONSTA risperidone injection, powder, for suspension, extended release

Product Information Route of Administration INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength risperidone (risperidone) risperidone 12.5 mg in 2 mL

Packaging # Item Code Package Description Multilevel Packaging 1 2 mL in 1 VIAL None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021346 10/29/2003

Part 2 of 2 DILUENT diluent injection, solution

Product Information Route of Administration INTRAMUSCULAR DEA Schedule

Inactive Ingredients Ingredient Name Strength polysorbate 20 carboxymethylcellulose sodium, unspecified form sodium phosphate, dibasic, heptahydrate anhydrous citric acid sodium chloride sodium hydroxide water

Packaging # Item Code Package Description Multilevel Packaging 1 2 mL in 1 SYRINGE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021346 10/29/2003

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021346 10/29/2003

RISPERDAL CONSTA risperidone kit

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50458-306

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:50458-306-11 1 KIT in 1 BOX None

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 VIAL 2 mL Part 2 1 SYRINGE 2 mL

Part 1 of 2 RISPERDAL CONSTA risperidone injection, powder, for suspension, extended release

Product Information Route of Administration INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength risperidone (risperidone) risperidone 25 mg in 2 mL

Packaging # Item Code Package Description Multilevel Packaging 1 2 mL in 1 VIAL None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021346 10/29/2003

Part 2 of 2 DILUENT diluent injection, solution

Product Information Route of Administration INTRAMUSCULAR DEA Schedule

Inactive Ingredients Ingredient Name Strength polysorbate 20 carboxymethylcellulose sodium, unspecified form sodium phosphate, dibasic, heptahydrate anhydrous citric acid sodium chloride sodium hydroxide water

Packaging # Item Code Package Description Multilevel Packaging 1 2 mL in 1 SYRINGE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021346 10/29/2003

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021346 10/29/2003

RISPERDAL CONSTA risperidone kit

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50458-307

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:50458-307-11 1 KIT in 1 BOX None

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 VIAL 2 mL Part 2 1 SYRINGE 2 mL

Part 1 of 2 RISPERDAL CONSTA risperidone injection, powder, for suspension, extended release

Product Information Route of Administration INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength risperidone (risperidone) risperidone 37.5 mg in 2 mL

Packaging # Item Code Package Description Multilevel Packaging 1 2 mL in 1 VIAL None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021346 10/29/2003

Part 2 of 2 DILUENT diluent injection, solution

Product Information Route of Administration INTRAMUSCULAR DEA Schedule

Inactive Ingredients Ingredient Name Strength polysorbate 20 carboxymethylcellulose sodium, unspecified form sodium phosphate, dibasic, heptahydrate anhydrous citric acid sodium chloride sodium hydroxide water

Packaging # Item Code Package Description Multilevel Packaging 1 2 mL in 1 SYRINGE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021346 10/29/2003

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021346 10/29/2003

RISPERDAL CONSTA risperidone kit

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50458-308

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:50458-308-11 1 KIT in 1 BOX None

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 VIAL 2 mL Part 2 1 SYRINGE 2 mL

Part 1 of 2 RISPERDAL CONSTA risperidone injection, powder, for suspension, extended release

Product Information Route of Administration INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength risperidone (risperidone) risperidone 50 mg in 2 mL

Packaging # Item Code Package Description Multilevel Packaging 1 2 mL in 1 VIAL None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021346 10/29/2003

Part 2 of 2 DILUENT diluent injection, solution

Product Information Route of Administration INTRAMUSCULAR DEA Schedule

Inactive Ingredients Ingredient Name Strength polysorbate 20 carboxymethylcellulose sodium, unspecified form sodium phosphate, dibasic, heptahydrate anhydrous citric acid sodium chloride sodium hydroxide water

Packaging # Item Code Package Description Multilevel Packaging 1 2 mL in 1 SYRINGE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021346 10/29/2003

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021346 10/29/2003

Labeler — Janssen Pharmaceuticals, Inc. (063137772)

Establishment
Name	Address	ID/FEI	Operations
Alkermes, Inc.		858582083	MANUFACTURE (50458-309), MANUFACTURE (50458-306), MANUFACTURE (50458-307), MANUFACTURE (50458-308)

Establishment
Name	Address	ID/FEI	Operations
Janssen Pharmaceutical Sciences Unlimited Company		985639841	API MANUFACTURE (50458-309), API MANUFACTURE (50458-306), API MANUFACTURE (50458-307), API MANUFACTURE (50458-308)

Establishment
Name	Address	ID/FEI	Operations
Cilag AG		483237103	MANUFACTURE (50458-309), MANUFACTURE (50458-306), MANUFACTURE (50458-307), MANUFACTURE (50458-308)

Establishment
Name	Address	ID/FEI	Operations
Vetter		344217323	MANUFACTURE (50458-309), MANUFACTURE (50458-306), MANUFACTURE (50458-307), MANUFACTURE (50458-308)

Revised: 07/2020 Janssen Pharmaceuticals, Inc.