Baclofen (Page 2 of 2)

Dosage and Administration Section


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 If benefits are not evident after a reasonable trial period, patients should be slowly withdrawn from the drug (see WARNINGS, Abrupt Drug Withdrawal).

Principal Display Panel

label 1
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label 2
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label 3
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lable 1label 1label 2label 3lable 1
baclofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:80425-0156(NDC:31722-998)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 9mm
Flavor Imprint Code I114
# Item Code Package Description Multilevel Packaging
1 NDC:80425-0156-3 90 TABLET in 1 BOTTLE None
2 NDC:80425-0156-1 30 TABLET in 1 BOTTLE None
3 NDC:80425-0156-2 60 TABLET in 1 BOTTLE None
4 NDC:80425-0156-4 120 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212378 10/09/2020
Labeler — Advanced Rx Pharmacy of Tennessee, LLC (117023142)
Name Address ID/FEI Operations
Advanced Rx Pharmacy of Tennessee, LLC 117023142 repack (80425-0156)

Revised: 05/2023 Advanced Rx Pharmacy of Tennessee, LLC

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