Carisoprodol (Page 4 of 4)
16 HOW SUPPLIED/STORAGE AND HANDLING
350 mg Tablets: white, round, unscored tablets debossed “2410 V” on one side and plain on the reverse side; available in bottles of 15, 20, 21, 30, 42, 60, 90 and 120.
Storage:
Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].
17 PATIENT COUNSELING INFORMATION
Patients should be advised to contact their physician if they experience any adverse reactions to carisoprodol tablets.
17.1 Sedation
Since carisoprodol tablets may cause drowsiness and/or dizziness, patients should be advised to assess their individual response to carisoprodol tablets before engaging in potentially hazardous activities such as driving a motor vehicle or operating machinery [see Warnings and Precautions (5.1)].
17.2 Avoidance of Alcohol and Other CNS Depressants
Patients should be advised to avoid alcoholic beverages while taking carisoprodol tablets and to check with their doctor before taking other CNS depressants such as benzodiazepines, opioids, tricyclic antidepressants, sedating antihistamines, or other sedatives [see Warnings and Precautions (5.1)].
17.3 Carisoprodol Tablets Should Only Be Used for Short-Term Treatment
Patients should be advised that treatment with carisoprodol tablets should be limited to acute use (up to two or three weeks) for the relief of acute, musculoskeletal discomfort. If symptoms still persist, patients should contact their healthcare provider for further evaluation.
Manufactured for:
QUALITEST PHARMACEUTICALS
Huntsville, AL 35811
Repackaged by:
Rebel Distributors Corp.
Thousand Oaks, CA 91320
PRINCIPAL DISPLAY PANEL
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Labeler — Rebel Distributors Corp. (118802834) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Rebel Distributors Corp. | 118802834 | repack, relabel |
Revised: 12/2009 Rebel Distributors Corp.
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