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 40-80 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 If benefits are not evident after a reasonable trial period, patients should be slowly withdrawn from the drug (see WARNINGSAbrupt Drug Withdrawal).

HOW SUPPLIED

Baclofen Tablets, USP are supplied as:

10 mg: White colored, circular, flat, uncoated tablets with ‘N029’ debossed on one side and scoreline on the other side.

Boxes of 10X10 UD 100, NDC 63739-479-10

20 mg: White colored, circular, flat, uncoated tablets with ‘N030’ debossed on one side and scoreline on the other side.

Boxes of 10×10 UD 100, NDC 63739-480-10

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

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

Split tablet to be stored at controlled room temperature (20° to 25°C) for not more than 2 weeks.

KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN.

Manufactured by:
Piramal Enterprises Limited,
Plot No 67-70, Sector — 2, Pithampur, Madhya Pradesh 454775
INDIA.

Distributed by:
McKesson Corporation
4971 Southridge Blvd, Suite 101
Memphis, TN 38141

21340

August 2020

10 mg

20 mg

BACLOFEN baclofen tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63739-479(NDC:16714-071) 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 SILICON DIOXIDE MICROCRYSTALLINE CELLULOSE MAGNESIUM STEARATE STARCH, POTATO POVIDONE K30

Product Characteristics Color white Score 2 pieces Shape ROUND (FLAT) Size 8mm Flavor Imprint Code N029 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:63739-479-10 10 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK 1 10 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (63739-479-10)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078504 01/01/2011

BACLOFEN baclofen tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63739-480(NDC:16714-072) 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 SILICON DIOXIDE MICROCRYSTALLINE CELLULOSE MAGNESIUM STEARATE STARCH, POTATO POVIDONE K30

Product Characteristics Color white Score 2 pieces Shape ROUND (FLAT) Size 10mm Flavor Imprint Code N030 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:63739-480-10 10 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK 1 10 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (63739-480-10)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078401 01/01/2011

Labeler — Mckesson Corporation DBA SKY Packaginng (140529962)

Revised: 01/2021 Mckesson Corporation DBA SKY Packaginng