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

Package Label
(click image for full-size original)
CARISOPRODOL
carisoprodol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:21695-021(NDC:0603-2582)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARISOPRODOL (CARISOPRODOL) CARISOPRODOL 350 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
HYPROMELLOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 12mm
Flavor Imprint Code 2410;V
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21695-021-15 15 TABLET (15 TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:21695-021-20 20 TABLET (20 TABLET) in 1 BOTTLE, PLASTIC None
3 NDC:21695-021-21 21 TABLET (21 TABLET) in 1 BOTTLE, PLASTIC None
4 NDC:21695-021-30 30 TABLET (30 TABLET) in 1 BOTTLE, PLASTIC None
5 NDC:21695-021-42 42 TABLET (42 TABLET) in 1 BOTTLE, PLASTIC None
6 NDC:21695-021-60 60 TABLET (60 TABLET) in 1 BOTTLE, PLASTIC None
7 NDC:21695-021-90 90 TABLET (90 TABLET) in 1 BOTTLE, PLASTIC None
8 NDC:21695-021-72 120 TABLET (120 TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040124 01/24/1996
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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