Prescription Drug Information: Buspirone Hydrochloride (Page 5 of 5)

Storage and Handling

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 using a child-resistant closure.

PHARMACIST: Patient Instruction Sheet attached to prescribing information. Additional copies are provided separately.

REFERENCE

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

The brands listed are trademarks of their respective owners.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Marketed/ Packaged by:
GSMS, Inc.
Camarillo, CA 93012 USA

Revised: 12/2016
BUSPAS:R15ppt

Buspirone Hydrochloride Tablets, USP Patient Instruction Sheet

HOW TO USE:

Buspirone Hydrochloride
Tablets, USP
15 mg and 30 mg Tablets

in convenient multi-scored tablet form

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

This multi-scored 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)5 mg (one-third of a tablet)7.5 mg (one-half of a tablet)

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

Breaking Multi-Scored Tablet

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Marketed/ Packaged by:
GSMS, Inc.
Camarillo, CA 93012 USA
Revised: 12/2016
PL:BUSPAS:R6p

PRINCIPAL DISPLAY PANEL — 5 mg

NDC 60429-291-01

busPIRone
Hydrochloride
Tablets, USP
5 mg

Rx only 100 Tablets

Each tablet contains: Buspirone
hydrochloride, USP 5 mg

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Keep this and all medication
out of the reach of children.

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

Usual Dosage: See accompanying
prescribing information.

Marketed/ Packaged by:
GSMS, Inc. Camarillo, CA 93012 USA

GSMS.us

RM1140A7

//rxdruglabels.com/lib/images-rx/buspirone-hydrochloride-62/60429-291-01lb-buspirone-hcl-5-mg-tabs-rev-sep-2011-10-30-2018-300x223.jpg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 mg

NDC 60429-292-05

busPIRone
Hydrochloride
Tablets, USP
10 mg

Rx only 500 Tablets

Each tablet contains: Buspirone
hydrochloride, USP 10 mg

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Keep this and all medication
out of the reach of children.

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

Usual Dosage: See accompanying
prescribing information.

Marketed/ Packaged by:
GSMS, Inc. Camarillo, CA 93012 USA

GSMS.us

RM1150A7

//rxdruglabels.com/lib/images-rx/buspirone-hydrochloride-62/60429-292-05lb-buspirone-hcl-10mg-tabs-rev-dec-2016-10-30-2018-300x231.jpg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 15 mg

NDC 60429-293-60

busPIRone
Hydrochloride
Tablets, USP
15 mg

PHARMACIST: Dispense the accompanying
Patient Instruction Sheet to each patient.

Rx only 60 Tablets

Each tablet contains: Buspirone
hydrochloride, USP 15 mg

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Keep this and all medication
out of the reach of children.

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

Usual Dosage: See accompanying
prescribing information.

Marketed/ Packaged by:
GSMS, Inc. Camarillo, CA 93012 USA

GSMS.us

RM1165D7

//rxdruglabels.com/lib/images-rx/buspirone-hydrochloride-62/60429-293-60lb-buspirone-hcl-15-mg-tabs-rev-oct-2015-10-30-2018-300x231.jpg
(click image for full-size original)
BUSPIRONE HYDROCHLORIDE buspirone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-291(NDC:0378-1140)
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
MICROCRYSTALLINE CELLULOSE
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color white Score 2 pieces
Shape OVAL Size 9mm
Flavor Imprint Code M;B1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60429-291-01 100 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:60429-291-05 500 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076008 02/09/2015 11/23/2015
BUSPIRONE HYDROCHLORIDE buspirone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-292(NDC:0378-1150)
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
MICROCRYSTALLINE CELLULOSE
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color white Score 2 pieces
Shape OVAL Size 12mm
Flavor Imprint Code M;B2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60429-292-01 100 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:60429-292-05 500 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076008 02/09/2015 03/01/2021
BUSPIRONE HYDROCHLORIDE buspirone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-293(NDC:0378-1165)
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
MICROCRYSTALLINE CELLULOSE
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color white Score 3 pieces
Shape OVAL (capsule-shaped) Size 18mm
Flavor Imprint Code M;B3;5;5;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60429-293-60 60 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:60429-293-05 500 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076008 02/09/2015 02/01/2021
Labeler — Golden State Medical Supply, Inc. (603184490)
Establishment
Name Address ID/FEI Operations
Golden State Medical Supply, Inc. 603184490 repack (60429-291), repack (60429-292), repack (60429-293), relabel (60429-291), relabel (60429-292), relabel (60429-293)

Revised: 03/2020 Golden State Medical Supply, Inc.

RxDrugLabels.com provides trustworthy package insert and label information about marketed prescription drugs as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by RxDrugLabels.com. Every individual prescription drug label and package insert entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

Medication Sections

Medication Information by RSS

As a leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. RxDrugLabels.com provides the full prescription-only subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2020. All Rights Reserved.