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 If benefits are not evident after a reasonable trial period, patients should be slowly withdrawn from the drug (see WARNINGS, Abrupt Drug Withdrawal).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, 5 mg are available as a white round convex tablet debossed with “LCI” on one side and “1333” on the other side. Available in bottles of 90 (NDC 62135-472-90).

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 bottles of 90 (NDC 62135-473-90) and 500 (NDC 62135-473-05).

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 bottles of 90 (NDC 62135-474-90) and 500 (NDC 62135-474-05).

PHARMACIST: Dispense in a well-closed container as defined in the USP, with a child-resistant closure (as required).

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

Manufactured for:
Chartwell RX, LLC.
Congers, NY 10920

L71279
Rev. 02/2023

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Baclofen Tablets, USP 5 mg- NDC 62135-472-90 — 90s-bottle label

Baclofen Tablets USP
(click image for full-size original)

Baclofen Tablets, USP 10 mg- NDC 62135-473-90 — 90s-bottle label

Baclofen Tablets USP
(click image for full-size original)

Baclofen Tablets, USP 10 mg- NDC 62135-473-05 — 500s-bottle label

Baclofen Tablets USP
(click image for full-size original)

Baclofen Tablets, USP 20 mg- NDC 62135-474-90 — 90s-bottle label

Baclofen Tablets USP
(click image for full-size original)

Baclofen Tablets, USP 20 mg- NDC 62135-474-05 — 500s-bottle label

Baclofen Tablets USP
(click image for full-size original)

BACLOFEN
baclofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62135-472
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACLOFEN (BACLOFEN) BACLOFEN 5 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
SILICON DIOXIDE
MAGNESIUM STEARATE
Product Characteristics
Color white Score no score
Shape ROUND Size 6mm
Flavor Imprint Code LCI;1333
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62135-472-90 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077241 09/22/2021
BACLOFEN
baclofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62135-473
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 Score 2 pieces
Shape ROUND Size 9mm
Flavor Imprint Code LCI;1330
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62135-473-90 90 TABLET in 1 BOTTLE None
2 NDC:62135-473-05 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077241 07/01/2007
BACLOFEN
baclofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62135-474
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 Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code LCI;1337
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62135-474-90 90 TABLET in 1 BOTTLE None
2 NDC:62135-474-05 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077241 12/20/2005
Labeler — Chartwell RX, LLC (079394054)

Revised: 06/2023 Chartwell RX, LLC

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