Prescription Drug Information: Carisoprodol (Page 4 of 4)

16 HOW SUPPLIED/STORAGE AND HANDLING

Carisoprodol tablets USP, 350 mg : White to off-white circular biconvex tablets, debossed with logo-mark “OP” and product number “35″ on one side and no mark on the other side; available in bottles of 100 (NDC 59746-705-01), bottles of 1,000 (NDC 59746-705-10), and bottles of 500 (NDC 59746-705-05).

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.

Revised: 01/2018

Manufactured by: Orient Pharma Co., Ltd. Yunlin, Taiwan

Distributed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801. USA

PRINCIPAL DISPLAY PANEL — 100, 500 and 1000 Tablets Bottle Label

NDC 59746-705-01 100 Tablets

CIV

Carisoprodol Tablets, USP

350 mg

Rx Only

orient PHARMA CO.,Ltd.

3840261-6555-43cc-afaa-8c21c7d2f452
(click image for full-size original)

NDC 59746-705-05 500 Tablets

CIV

Carisoprodol Tablets, USP

350 mg

Rx Only

orient PHARMA CO.,Ltd.

aa616d7-09db-42f5-b983-d12ad959c50f
(click image for full-size original)

NDC 59746-705-10 1000 Tablets

CIV

Carisoprodol Tablets, USP

350 mg

Rx Only

orient PHARMA CO.,Ltd.

09ca67f-40bb-4347-b784-15b787e81f3b
(click image for full-size original)
CARISOPRODOL
carisoprodol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59746-705
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
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
CROSCARMELLOSE SODIUM
POVIDONE K30
TALC
STARCH, CORN
Product Characteristics
Color white Score no score
Shape ROUND Size 12mm
Flavor Imprint Code OP;35
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59746-705-01 100 TABLET in 1 BOTTLE None
2 NDC:59746-705-10 1000 TABLET in 1 BOTTLE None
3 NDC:59746-705-05 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205085 06/01/2015 05/31/2020
Labeler — Jubilant Cadista Pharmaceuticals Inc. (022490515)
Registrant — Orient Pharma Co., Ltd (658849810)
Establishment
Name Address ID/FEI Operations
Orient Pharma Co., Ltd 658849810 manufacture (59746-705), analysis (59746-705)

Revised: 05/2020 Jubilant Cadista Pharmaceuticals Inc.

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