Baclofen (Page 2 of 2)

DOSAGE AND ADMINISTRATION

The determination of optimal dosage requires individual titration. Start therapy at a low dosage and increase gradually until optimum effect is achieved (usually between 40 to 80 mg daily).

The following dosage titration schedule is suggested:

5 mg t.i.d. for 3 days
10 mg t.i.d. for 3 days
15 mg t.i.d. for 3 days
20 mg t.i.d. for 3 days

Thereafter additional increases may be necessary but the total daily dose should not exceed a maximum of 80 mg daily (20 mg q.i.d.).

The lowest dose compatible with an optimal response is recommended. If benefits are not evident after a reasonable trial period, patients should be slowly withdrawn from the drug (see WARNINGS, Abrupt Drug Withdrawal).

HOW SUPPLIED

Baclofen Tablets USP, 10 mg are available as a white round flat-faced beveled edge bisected tablet debossed with “LCI” over “1330” on one side and plain on the other side, containing 10 mg Baclofen USP. Available in unit dose packaged of 100 (10 x 10) NDC 68084-855-01

Baclofen Tablets USP, 20 mg are available as a white round flat-faced beveled edge bisected tablet debossed with “LCI” over “1337” on one side and plain on the other side, containing 20 mg Baclofen USP. Available in unit dose packaged of 100 (10 x 10) NDC 68084-868-01

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

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

PACKAGING INFORMATION

American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Lannett Company, Inc. as follows:
(10 mg / 100 UD) NDC 68084-855-01 packaged from NDC 0527-1330
(20 mg / 100 UD) NDC 68084-868-01 packaged from NDC 0527-1337

Distributed by:
American Health Packaging Columbus, OH 43217

8285501/0520

Package/Label Display Panel – Carton – 10 mg

10 mg Baclofen Tablets Carton
(click image for full-size original)

NDC 68084- 855 -01

Baclofen
Tablets, USP

10 mg

100 Tablets (10 x 10)               Rx Only

Each Tablet Contains:
Baclofen, USP………………………………………………10 mg

Usual Dosage: See package insert for full prescribing information.

Store at 20° to 25°C (68° to 77°F); excursions permitted between
15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

The drug product contained in this package is from
NDC # 0527-1330, Lannett Company, Inc.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

085501 0285501/1118A

Package/Label Display Panel – Blister – 10 mg

10 mg Baclofen Tablet Blister
(click image for full-size original)

Baclofen Tablet, USP

10 mg

Package/Label Display Panel – Carton – 20 mg

20 mg Baclofen Tablets Carton
(click image for full-size original)

NDC 68084- 868 -01

Baclofen
Tablets, USP

20 mg

100 Tablets (10 x 10)               Rx Only

Each Tablet Contains:
Baclofen, USP………………………………………………20 mg

Usual Dosage: See package insert for full prescribing information.

Store at 20° to 25°C (68° to 77°F); excursions permitted between
15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

The drug product contained in this package is from
NDC # 0527-1337, Lannett Company, Inc.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

086801 0286801/1118

Package/Label Display Panel – Blister – 20 mg

20 mg Baclofen Tablet Blister
(click image for full-size original)

Baclofen Tablet, USP

20 mg

BACLOFEN baclofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-855(NDC:0527-1330)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACLOFEN (BACLOFEN) BACLOFEN 10 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
SILICON DIOXIDE
MAGNESIUM STEARATE
Product Characteristics
Color white (white) Score 2 pieces
Shape ROUND (flat-faced beveled edge) Size 9mm
Flavor Imprint Code LCI;1330
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68084-855-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (68084-855-11)
1 NDC:68084-855-11 1 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (68084-855-01)
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077241 03/04/2015
BACLOFEN baclofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-868(NDC:0527-1337)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACLOFEN (BACLOFEN) BACLOFEN 20 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
SILICON DIOXIDE
MAGNESIUM STEARATE
Product Characteristics
Color white (white) Score 2 pieces
Shape ROUND (flat-faced beveled edge) Size 10mm
Flavor Imprint Code LCI;1337
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68084-868-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (68084-868-11)
1 NDC:68084-868-11 1 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (68084-868-01)
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077241 03/04/2015
Labeler — American Health Packaging (929561009)
Establishment
Name Address ID/FEI Operations
American Health Packaging 929561009 repack (68084-855), repack (68084-868)

Revised: 06/2020 American Health Packaging

Page 2 of 2 1 2

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 © 2021. All Rights Reserved.