Buspirone Hydrochloride (Page 6 of 6)

HOW SUPPLIED

BusPIRone Hydrochloride Tablets USP, 5 mg are available as white to off-white, round, beveled-edge tablets, debossed “TV” and “53” on one side and scored on the other side, packaged in bottles of 100 (NDC 0093-0053-01) and 500 (NDC 0093-0053-05) tablets.

BusPIRone Hydrochloride Tablets USP, 10 mg are available as white to off-white, round, beveled-edge tablets, debossed “TEVA” on one side and scored and debossed “54” on the other side, packaged in bottles of 100 (NDC 0093-0054-01) and 500 (NDC 0093-0054-05) tablets.

BusPIRone Hydrochloride Tablets USP, 15 mg are available as white to off-white, rectangular, tablets that can either be bisected or trisected, debossed “TV” and “1003” on bisect segments, and debossed “5” on each trisect segment, and packaged in bottles of 100 (NDC 0093-1003-01) and 500 (NDC 0093-1003-05) tablets.

BusPIRone Hydrochloride Tablets USP, 30 mg are available as white to off-white, rectangular, tablets that can either be bisected or trisected, debossed “TV” and “5200” on bisect segments, and debossed “10” on each trisect segment, and packaged in bottles of 60 (NDC 0093-5200-06) and 500 (NDC 0093-5200-05) tablets.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

REFERENCES

1. American Psychiatric Association, Ed.: Diagnostic and Statistical Manual of Mental Disorders—III, American Psychiatric Association, May 1980.

Manufactured In Croatia By:

Pliva Hrvatska d.o.o.

Zagreb, Croatia

Manufactured For:

Teva Pharmaceuticals USA, Inc.

North Wales, PA 19454

Rev. Z 12/2016

PATIENT INFORMATION

BUSPIRONE HYDROCHLORIDE TABLETS

Rx only

HOW TO USE:

BUSPIRONE HYDROCHLORIDE TABLETS, 15 mg

Response to buspirone varies among individuals. Your physician may find it necessary to adjust your dosage to obtain the proper response.

This tablet design makes dosage adjustments easy. Each tablet is scored and can be broken accurately to provide any of the following dosages.

If your doctor prescribed the 15 mg tablet:

15 mg (the entire tablet)

10 mg (two-thirds of a tablet)

7.5 mg (one-half of a tablet)

5 mg (one-third of a tablet)

To break a tablet accurately and easily, hold the tablet between your thumbs and index fingers close to the appropriate tablet score (groove) as shown below. Then, with the tablet score facing you, apply pressure and snap the tablet segments apart (segments breaking incorrectly should not be used).

Manufactured In Croatia By:

Pliva Hrvatska d.o.o.

Zagreb, Croatia

Manufactured For:

Teva Pharmaceuticals USA, Inc.

North Wales, PA 19454

Rev. H 12/2016

PATIENT INFORMATION

BUSPIRONE HYDROCHLORIDE TABLETS

Rx only

HOW TO USE:

BUSPIRONE HYDROCHLORIDE TABLETS, 30 mg

Response to buspirone varies among individuals. Your physician may find it necessary to adjust your dosage to obtain the proper response.

This tablet design makes dosage adjustments easy. Each tablet is scored and can be broken accurately to provide any of the following dosages.

If your doctor prescribed the 30 mg tablet:

30 mg (the entire tablet)

20 mg (two-thirds of a tablet)

15 mg (one-half of a tablet)

10 mg (one-third of a tablet)

To break a tablet accurately and easily, hold the tablet between your thumbs and index fingers close to the appropriate tablet score (groove) as shown below. Then, with the tablet score facing you, apply pressure and snap the tablet segments apart (segments breaking incorrectly should not be used).

Manufactured In Croatia By:

Pliva Hrvatska d.o.o.

Zagreb, Croatia

Manufactured For:

Teva Pharmaceuticals USA, Inc.

North Wales, PA 19454

Rev. H 12/2016

Package/Label Display Panel

NDC 0093-0053 -01

BusPIRone
Hydrochloride
Tablets USP 5 mg

Rx only

100 TABLETS

TEVA

Package/Label Display Panel

NDC 0093-0054 -01

BusPIRone
Hydrochloride
Tablets USP 10 mg

Rx only

100 TABLETS

TEVA

Package/Label Display Panel

NDC 0093-1003 -01

BusPIRone
Hydrochloride
Tablets USP
15 mg

PHARMACIST: PLEASE DISPENSE WITHATTACHED PATIENT INFORMATION LEAFLET

Rx only

100 TABLETS

TEVA

Package/Label Display Panel

NDC 0093-5200 -06

BusPIRone
Hydrochloride
Tablets USP
30 mg

PHARMACIST: PLEASE DISPENSE WITHATTACHED PATIENT INFORMATION LEAFLET

Rx only

60 TABLETS

TEVA

BUSPIRONE HYDROCHLORIDE buspirone hydrochloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-0053 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BUSPIRONE HYDROCHLORIDE (BUSPIRONE) BUSPIRONE HYDROCHLORIDE 5 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE SILICON DIOXIDE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics Color white (white to off-white) Score 2 pieces Shape ROUND Size 6mm Flavor Imprint Code TV;53 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0093-0053-01 100 TABLET in 1 BOTTLE None 2 NDC:0093-0053-05 500 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075022 02/28/2002

BUSPIRONE HYDROCHLORIDE buspirone hydrochloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-0054 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BUSPIRONE HYDROCHLORIDE (BUSPIRONE) BUSPIRONE HYDROCHLORIDE 10 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE SILICON DIOXIDE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics Color white (white to off-white) Score 2 pieces Shape ROUND Size 8mm Flavor Imprint Code TEVA;54 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0093-0054-01 100 TABLET in 1 BOTTLE None 2 NDC:0093-0054-05 500 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075022 02/28/2002

BUSPIRONE HYDROCHLORIDE buspirone hydrochloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-1003 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BUSPIRONE HYDROCHLORIDE (BUSPIRONE) BUSPIRONE HYDROCHLORIDE 15 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE SILICON DIOXIDE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics Color white (white to off-white) Score 3 pieces Shape RECTANGLE Size 15mm Flavor Imprint Code TV;1003;5;5;5 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0093-1003-01 100 TABLET in 1 BOTTLE None 2 NDC:0093-1003-05 500 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075022 03/01/2002

BUSPIRONE HYDROCHLORIDE buspirone hydrochloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-5200 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BUSPIRONE HYDROCHLORIDE (BUSPIRONE) BUSPIRONE HYDROCHLORIDE 30 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE SILICON DIOXIDE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics Color white (white to off-white) Score 3 pieces Shape RECTANGLE Size 17mm Flavor Imprint Code TV;5200;10;10;10 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0093-5200-05 500 TABLET in 1 BOTTLE None 2 NDC:0093-5200-06 60 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075022 03/26/2004

Labeler — Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 12/2016 Teva Pharmaceuticals USA, Inc.