Risperidone (Page 12 of 12)

16. HOW SUPPLIED/STORAGE AND HANDLING

Risperidone Tablets, 0.25 mg are supplied as oblong, biconvex, white, coated tablet, engraved rph on one side and n28 on the other and are available in:
bottles of 100 NDC 58165-028-01
bottles of 500 NDC 58165-028-02
blisters (10 x 15 tablets cards) NDC 58165-028-03.

Risperidone Tablets, 0.5 mg are supplied as oblong, biconvex, white, coated tablet, engraved rph on one side and n29 on the other and are available in:
bottles of 100 NDC 58165-029-01
bottles of 500 NDC 58165-029-02
blisters (10 x 15 tablets cards) NDC 58165-029-03.

Risperidone Tablets, 1 mg are supplied as oblong, biconvex, white, coated tablet, engraved rph on one side and n30 on the other and are available in:
bottles of 100 NDC 58165-030-01
bottles of 500 NDC 58165-030-02
blisters (10 x 15 tablets cards) NDC 58165-030-03.

Risperidone Tablets, 2 mg are supplied as oblong, biconvex, white, coated tablet, engraved rph on one side and n31 on the other and are available in:
bottles of 100 NDC 58165-031-01
bottles of 500 NDC 58165-031-02
blisters (10 x 15 tablets cards) NDC 58165-031-03.

Risperidone Tablets, 3 mg are supplied as oblong, biconvex, white, coated tablet, engraved rph on one side and n32 on the other and are available in:
bottles of 100 NDC 58165-032-01
bottles of 500 NDC 58165-032-02
blisters (10 x 15 tablets cards) NDC 58165-032-03.

Risperidone Tablets, 4 mg are supplied as oblong, biconvex, white, coated tablet, engraved rph on one side and n33 on the other and are available in:
bottles of 100 NDC 58165-033-01
bottles of 500 NDC 58165-033-02
blisters (10 x 15 tablets cards) NDC 58165-033-03.

Storage and Handling

Risperidone Tablets should be stored at controlled room temperature 15°-25°C (59°-77°F).
Protect from light and moisture.
Keep out of reach of children.

17. PATIENT COUNSELING INFORMATION

Physicians are advised to discuss the following issues with patients for whom they prescribe risperidone:

17.1 Orthostatic Hypotension

Patients should be advised of the risk of orthostatic hypotension, especially during the period of initial dose titration [see Warnings and Precautions (5.7)].

17.2 Interference with Cognitive and Motor Performance

Since risperidone has the potential to impair judgment, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that risperidone therapy does not affect them adversely [see Warnings and Precautions (5.9)].

17.3 Pregnancy

Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy [see Use in Specific Populations (8.1)].

17.4 Nursing

Patients should be advised not to breast-feed an infant if they are taking risperidone [see Use in Specific Populations (8.3)].

17.5 Concomitant Medication

Patients should be advised to inform their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs, since there is a potential for interactions [see Drug Interactions (7)].

17.6 Alcohol

Patients should be advised to avoid alcohol while taking risperidone [see Drug Interactions (7.1)].

Revised May 2010
Risperidone Tablets are manufactured by:
ratiopharm inc.
Canada J7J 1P31 800 337 2584

PRINCIPAL DISPLAY PANEL

0-25mg
(click image for full-size original)
0-5mg
(click image for full-size original)
1mg
(click image for full-size original)
2mg
(click image for full-size original)
3mg
(click image for full-size original)
4mg
(click image for full-size original)

150 TABLETS

NDC 58165-029-03

risperidone tablets

0.5 mg

Rx only

ratiopharm

Each tablet contains: 0.5 mg of risperidone.

DOSAGE: See accompanying package insert.

Store at 15-25°C (59-77°F). See USP Controlled Room Temperature. Protect from light and moisture.

KEEP OUT OF THE REACH OF CHILDREN.

This unit-dose package is not child-resistant. If dispensed for outpatient use, a child-resistant container should be used.

Manufactured by: ratiopharm inc. ,Mirabel, Canada J7J 1P3

RISPERIDONE risperidone tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58165-028
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Risperidone (Risperidone) Risperidone .25 mg
Product Characteristics
Color WHITE Score no score
Shape OVAL (oblong,biconvex) Size 8mm
Flavor Imprint Code rph;n28
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58165-028-01 100 TABLET, COATED (TABLET) in 1 BOTTLE None
2 NDC:58165-028-02 500 TABLET, COATED (TABLET) in 1 BOTTLE None
3 NDC:58165-028-03 150 TABLET, COATED (TABLET) in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077784 06/08/2010
RISPERIDONE risperidone tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58165-029
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Risperidone (Risperidone) Risperidone .5 mg
Product Characteristics
Color WHITE Score no score
Shape OVAL (oblong, biconvex) Size 9mm
Flavor Imprint Code rph;n29
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58165-029-01 100 TABLET, COATED (TABLET) in 1 BOTTLE None
2 NDC:58165-029-02 500 TABLET, COATED (TABLET) in 1 BOTTLE None
3 NDC:58165-029-03 150 TABLET, COATED (TABLET) in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077784 06/08/2010
RISPERIDONE risperidone tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58165-030
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Risperidone (Risperidone) Risperidone 1 mg
Product Characteristics
Color WHITE Score no score
Shape OVAL (oblong, biconvex) Size 12mm
Flavor Imprint Code rph;n30
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58165-030-01 100 TABLET, COATED (TABLET) in 1 BOTTLE None
2 NDC:58165-030-02 500 TABLET, COATED (TABLET) in 1 BOTTLE None
3 NDC:58165-030-03 150 TABLET, COATED (TABLET) in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077784 06/08/2010
RISPERIDONE risperidone tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58165-031
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Risperidone (Risperidone) Risperidone 2 mg
Product Characteristics
Color WHITE Score no score
Shape OVAL (oblong, biconvex) Size 12mm
Flavor Imprint Code rph;031
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58165-031-01 100 TABLET, COATED (TABLET) in 1 BOTTLE None
2 NDC:58165-031-02 500 TABLET, COATED (TABLET) in 1 BOTTLE None
3 NDC:58165-031-03 150 TABLET, COATED (TABLET) in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077784 06/08/2010
RISPERIDONE risperidone tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58165-032
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Risperidone (Risperidone) Risperidone 3 mg
Product Characteristics
Color WHITE Score no score
Shape OVAL (oblong, biconvex) Size 14mm
Flavor Imprint Code rph;032
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58165-032-01 100 TABLET, COATED (TABLET) in 1 BOTTLE None
2 NDC:58165-032-02 500 TABLET, COATED (TABLET) in 1 BOTTLE None
3 NDC:58165-032-03 150 TABLET, COATED (TABLET) in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077784 06/08/2010
RISPERIDONE risperidone tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58165-033
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Risperidone (Risperidone) Risperidone 4 mg
Product Characteristics
Color WHITE Score no score
Shape OVAL (oblong, biconvex) Size 15mm
Flavor Imprint Code rph;033
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58165-033-01 100 TABLET, COATED (TABLET) in 1 BOTTLE None
2 NDC:58165-033-02 500 TABLET, COATED (TABLET) in 1 BOTTLE None
3 NDC:58165-033-03 150 TABLET, COATED (TABLET) in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077784 06/08/2010
Labeler — Ratiopharm Inc (253124150)
Establishment
Name Address ID/FEI Operations
Ratiopharm Inc 253124150 MANUFACTURE

Revised: 05/2010 Ratiopharm Inc

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.