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 mg to 80 mg daily).

The following dosage titration schedule is suggested:

5 mg t.i.d. (three times in a day) 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. (four times in a day)).

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 If benefits are not evident after a reasonable trial period, patients should be slowly withdrawn from the drug (see WARNINGS , Abrupt Drug Withdrawal).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 to off white, round, flat-faced, beveled-edge uncoated tablets debossed with “16” on one side and “09” on the other side, containing 5 mg baclofen, USP are supplied as follows:

NDC 70771-1586-1 in bottle of 100 tablets

Baclofen Tablets USP, 10 mg are available as a white to off white, round, flat-faced, beveled-edge uncoated tablet debossed with “1285” on one side and break line on the other side, containing 10 mg baclofen, USP are supplied as follows:

NDC 70771-1448-1 in bottle of 100 tablets

NDC 70771-1448-5 in bottle of 500 tablets

NDC 70771-1448-0 in bottle of 1000 tablets

Baclofen Tablets USP, 20 mg are available as a white to off white, round, flat-faced, beveled-edge uncoated tablet debossed with “1286” on one side and break line on the other side, containing 20 mg baclofen, USP are supplied as follows:

NDC 70771-1449-1 in bottle of 100 tablets

NDC 70771-1449-5 in bottle of 500 tablets

NDC 70771-1449-0 in bottle of 1000 tablets

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].

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

Manufactured by:

Cadila Healthcare Ltd.

Baddi, India

Rev.: 03/21

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1448-1 in bottles of 100 tablets

Baclofen Tablets, USP

10 mg

Rx only

NDC 70771-1449-1 in bottles of 100 tablets

Baclofen Tablets, USP

20 mg

Rx only

NDC 70771-1586-1 in bottles of 100 tablets

Baclofen Tablets, USP

5 mg

Rx only

BACLOFEN baclofen tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1448 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 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS CELLULOSE, MICROCRYSTALLINE MAGNESIUM STEARATE POVIDONE K30 SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN

Product Characteristics Color WHITE (white to off white) Score 2 pieces Shape ROUND Size 8mm Flavor Imprint Code 1285 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70771-1448-1 100 TABLET in 1 BOTTLE None 2 NDC:70771-1448-5 500 TABLET in 1 BOTTLE None 3 NDC:70771-1448-0 1000 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA211659 12/06/2018

BACLOFEN baclofen tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1449 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 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS CELLULOSE, MICROCRYSTALLINE MAGNESIUM STEARATE POVIDONE K30 SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN

Product Characteristics Color WHITE (white to off white) Score 2 pieces Shape ROUND Size 10mm Flavor Imprint Code 1286 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70771-1449-1 100 TABLET in 1 BOTTLE None 2 NDC:70771-1449-5 500 TABLET in 1 BOTTLE None 3 NDC:70771-1449-0 1000 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA211659 12/06/2018

BACLOFEN baclofen tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1586 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 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS CELLULOSE, MICROCRYSTALLINE MAGNESIUM STEARATE POVIDONE K30 SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN

Product Characteristics Color WHITE (white to off white) Score no score Shape ROUND Size 5mm Flavor Imprint Code 16;09 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70771-1586-1 100 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA211659 05/07/2020

Labeler — Cadila Healthcare Limited (918596198)

Registrant — Zydus Worldwide DMCC (557951127)

Establishment
Name	Address	ID/FEI	Operations
Cadila Healthcare Limited		677605858	ANALYSIS (70771-1448), ANALYSIS (70771-1449), ANALYSIS (70771-1586), MANUFACTURE (70771-1448), MANUFACTURE (70771-1449), MANUFACTURE (70771-1586)

Revised: 01/2022 Cadila Healthcare Limited