CARISOPRODOL (Page 4 of 4)

16 HOW SUPPLIED/STORAGE AND HANDLING

Carisoprodol Tablets, USP 350 mg: round, convex, white tablets, debossed with SG 109 on one side; available in bottles of 30 (NDC 50228-109-30), bottles of 100 (NDC 50228-109-01, bottles of 500 (NDC 50228-109-05) and the bottles of 1,000 (NDC 50228-109-10).

Storage:
Store at 20° to 25°C (68° to 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.

17.1 Sedation

Patients should be advised that carisoprodol may cause drowsiness and/or dizziness, and has been associated with motor vehicle accidents. Patients should be advised to avoid taking carisoprodol 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 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 Should Only Be Used for Short-Term Treatment

Patients should be advised that treatment with carisoprodol should be limited to acute use (up to two or three weeks) for the relief of acute, musculoskeletal discomfort. In the post-marketing experience with carisoprodol, cases of dependence, withdrawal, and abuse have been reported with prolonged use. If the musculoskeletal symptoms still persist, patients should contact their healthcare provider for further evaluation.

Manufactured by:
ScieGen Pharmaceuticals, Inc.
Hauppauge, NY 11788 USA Rev. 01/19

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL

pdp
(click image for full-size original)

CARISOPRODOL carisoprodol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45865-984(NDC:50228-109)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARISOPRODOL (CARISOPRODOL) CARISOPRODOL 350 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
LACTOSE MONOHYDRATE
STARCH, CORN
CROSCARMELLOSE SODIUM
POVIDONE, UNSPECIFIED
SILICON DIOXIDE
MAGNESIUM STEARATE
Product Characteristics
Color white Score no score
Shape ROUND Size 12mm
Flavor Imprint Code SG;109
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45865-984-30 30 TABLET in 1 BOTTLE None
2 NDC:45865-984-60 60 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203374 01/27/2014
Labeler — medsource pharmaceuticals (833685915)
Establishment
Name Address ID/FEI Operations
medsource pharmaceuticals 833685915 repack (45865-984)

Revised: 12/2019 medsource pharmaceuticals

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