Label: BACLOFEN- baclofen 20mg tablet
- NDC Code(s): 80425-0081-2
- Packager: Advanced Rx Pharmacy of Tennessee, LLC
- This is a repackaged label.
- Source NDC Code(s): 16714-072
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated November 16, 2020
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Dosage and Administration Section
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 If benefits are not evident after a reasonable trial period, patients should be slowly withdrawn from the drug (see WARNINGS, Abrupt Drug Withdrawal).
Indications and Usage Section
INDICATIONS AND USAGE
Baclofen tablets USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.
Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases.
Baclofen tablets USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.
The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.
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INGREDIENTS AND APPEARANCE
baclofen 20mg tablet
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:80425-0081(NDC:16714-072) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACLOFEN (UNII: H789N3FKE8) (BACLOFEN - UNII:H789N3FKE8) BACLOFEN 20 mg Product Characteristics Color white Score 2 pieces Shape ROUND Size 10mm Flavor Imprint Code N030 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80425-0081-2 60 in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078401 01/01/2011 Labeler - Advanced Rx Pharmacy of Tennessee, LLC (117023142) Establishment Name Address ID/FEI Business Operations Advanced Rx Pharmacy of Tennessee, LLC 117023142 repack(80425-0081)