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CARISOPRODOL IMMEDIATE RELEASE- carisoprodol tablet


  1. Patient Information
  2. Manufactured For:
  3. Manufactured By:

Patient Information 

Patients should be advised to contact their physician if they experience any adverse reactions to carisoprodol tablets USP.

Sedation

Advise patients that carisoprodol tablets USP may cause drowsiness and/or dizziness, and has been associated with motor vehicle accidents. Patients should be advised to avoid taking carisoprodol tablets USP before engaging in potentially hazardous activities such as driving a motor vehicle or operating machinery[see Warnings and Precautions (5.1)].

Avoidance of Alcohol and Other CNS Depressants

Advise patients to avoid alcoholic beverages while taking carisoprodol tablets USP 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)].

Carisoprodol tablets USP Should Only Be Used for Short-Term Treatment

Advise patients that treatment with carisoprodol tablets USP 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 tablets USP, 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.

Lactation

Advise nursing mothers using carisoprodol tablets USP to monitor neonates for signs of sedation[see Use in Specific Populations (8.2)].

Manufactured For: 

Vensun Pharmaceuticals, Inc.

Yardley, PA 19067.

Manufactured By: 

Strides Pharma Science Ltd.

Puducherry - 605 014, India.

Rev.03, January 2019



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