Risperidone (Page 12 of 12)

17.6 Alcohol

Advise patients to avoid alcohol while taking risperidone [see Drug Interactions (7.2)].

17.8 Metabolic Changes

Inform patients and caregivers that treatment with risperidone can be associated with hyperglycemia and diabetes mellitus, dyslipidemia, and weight gain [see Warnings and Precautions (5.5)].

17.9 Tardive Dyskinesia

Inform patients and caregivers about the risk of tardive dyskinesia [see Warnings and Precautions (5.4)].

Manufactured for:
QUALITEST PHARMACEUTICALS
Huntsville, AL 35811

8182241
Revised: 3/2016R9

PRINCIPAL DISPLAY PANEL

This is an image of the label for risperiDONE Tablets 0.25 mg 500 count.
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

This is an image of the label for risperiDONE Tablets 0.5 mg 500 count.
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

This is an image of the label for risperiDONE Tablets 1 mg 500 count.
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

This is an image of the label for risperiDONE Tablets 2 mg 500 count.
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

This is an image of the label for risperiDONE Tablets 3 mg 500 count.
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

This is an image of the label for risperiDONE Tablets 4 mg 500 count.
(click image for full-size original)

RISPERIDONE risperidone tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0603-5683
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RISPERIDONE (RISPERIDONE) RISPERIDONE 0.25 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
HYPROMELLOSES
LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
POLYVINYL ALCOHOL, UNSPECIFIED
TALC
FD&C YELLOW NO. 6
D&C YELLOW NO. 10
Product Characteristics
Color YELLOW (dark yellow) Score no score
Shape OVAL (capsule-shaped) Size 7mm
Flavor Imprint Code 5683;V
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0603-5683-20 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:0603-5683-28 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078707 12/29/2008 07/31/2016
RISPERIDONE risperidone tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0603-5684
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RISPERIDONE (RISPERIDONE) RISPERIDONE 0.5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
HYPROMELLOSES
LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
POLYVINYL ALCOHOL, UNSPECIFIED
TALC
FERRIC OXIDE RED
Product Characteristics
Color BROWN (reddish-brown) Score no score
Shape OVAL (capsule-shaped) Size 9mm
Flavor Imprint Code 5684;V
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0603-5684-20 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:0603-5684-28 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
3 NDC:0603-5684-32 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078707 12/29/2008 07/31/2016
RISPERIDONE risperidone tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0603-5685
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RISPERIDONE (RISPERIDONE) RISPERIDONE 1 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
HYPROMELLOSES
LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
STEARIC ACID
TRIACETIN
Product Characteristics
Color WHITE Score no score
Shape OVAL (capsule-shaped) Size 12mm
Flavor Imprint Code 5685;V
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0603-5685-20 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:0603-5685-28 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
3 NDC:0603-5685-32 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078707 12/29/2008 09/30/2016
RISPERIDONE risperidone tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0603-5686
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RISPERIDONE (RISPERIDONE) RISPERIDONE 2 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
HYPROMELLOSES
LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
POLYVINYL ALCOHOL, UNSPECIFIED
TALC
FD&C YELLOW NO. 6
FD&C RED NO. 40
Product Characteristics
Color PINK Score no score
Shape OVAL (capsule-shaped) Size 12mm
Flavor Imprint Code 5686;V
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0603-5686-20 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:0603-5686-28 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
3 NDC:0603-5686-32 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078707 12/29/2008 09/30/2016
RISPERIDONE risperidone tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0603-5689
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RISPERIDONE (RISPERIDONE) RISPERIDONE 3 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
HYPROMELLOSES
LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
POLYVINYL ALCOHOL, UNSPECIFIED
TALC
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW Score no score
Shape OVAL (capsule-shaped) Size 14mm
Flavor Imprint Code 5687;V
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0603-5689-20 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:0603-5689-28 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078707 12/29/2008 08/31/2016
RISPERIDONE risperidone tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0603-5688
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RISPERIDONE (RISPERIDONE) RISPERIDONE 4 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
HYPROMELLOSES
LACTOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
POLYVINYL ALCOHOL, UNSPECIFIED
TALC
FD&C YELLOW NO. 6
D&C YELLOW NO. 10
FD&C BLUE NO. 1
Product Characteristics
Color GREEN Score no score
Shape OVAL (capsule-shaped) Size 15mm
Flavor Imprint Code 5688;V
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0603-5688-20 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:0603-5688-28 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078707 12/29/2008 07/31/2016
Labeler — Qualitest Pharmaceuticals (011103059)
Establishment
Name Address ID/FEI Operations
Vintage Pharmaceuticals-Huntsville 825839835 ANALYSIS (0603-5683), ANALYSIS (0603-5684), ANALYSIS (0603-5685), ANALYSIS (0603-5689), ANALYSIS (0603-5686), ANALYSIS (0603-5688), LABEL (0603-5683), LABEL (0603-5684), LABEL (0603-5685), LABEL (0603-5689), LABEL (0603-5686), LABEL (0603-5688), MANUFACTURE (0603-5683), MANUFACTURE (0603-5684), MANUFACTURE (0603-5685), MANUFACTURE (0603-5686), MANUFACTURE (0603-5689), MANUFACTURE (0603-5688), PACK (0603-5683), PACK (0603-5684), PACK (0603-5685), PACK (0603-5689), PACK (0603-5686), PACK (0603-5688)

Revised: 03/2016 Qualitest Pharmaceuticals

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 © 2020. All Rights Reserved.