Skip to Content

Carisoprodol

Pronunciation

Dosage Form: tablet

Indications and Usage for Carisoprodol

Carisoprodol tablets USP is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.
Carisoprodol tablets USP should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration
[see Dosage and Administration (2)]

Carisoprodol Dosage and Administration

The recommended dose of Carisoprodol tablets USP is 250 mg to 350 mg three times a day and at bedtime. The recommended maximum duration of Carisoprodol tablets USP use is up to two or three weeks.

Dosage Forms and Strengths

250 mg Tablets: circular shaped, biconvex, white to off white colored, uncoated tablets, debossed  "S" and "434" on one side and plain on the other side
                                                                                                                                                     
350 mg Tablets: circular shaped, biconvex, white to off white colored, uncoated tablets, debossed  "S" and "435" on one side and plain on the other side

Contraindications

Carisoprodol tablets USP is contraindicated in patients with a history of acute intermittent porphyria or a hypersensitivity reaction to a carbamate such as meprobamate.

Warnings and Precautions

Sedation

Carisoprodol tablets USP has sedative properties (in the low back pain trials, 13% to 17% of patients who received Carisoprodol tablets USP experienced sedation compared to 6% of patients who received placebo) [see ADVERSE REACTIONS (6.1)] and may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a motor vehicle or operating machinery. There have been post-marketing reports of motor vehicle accidents associated with the use of Carisoprodol tablets USP.
Since the sedative effects of Carisoprodol tablets USP and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) may be additive, appropriate caution should be exercised with patients who take more than one of these CNS depressants simultaneously.


Abuse, Dependence and Withdrawal

Carisoprodol, the active ingredient in Carisoprodol tablets USP, has been subject to abuse, dependence, withdrawal, misuse, and criminal diversion.

[see Drug Abuse and Dependence (9.1, 9.2, 9.3)]. Abuse of Carisoprodol tablets USP poses a risk of overdosage which may lead to death, CNS and respiratory depression, hypotension, seizures, and other disorders [see Overdosage (10)].
Post-marketing experience cases of Carisoprodol abuse and dependence have been reported in patients with prolonged use and a history of drug abuse. Although most of these patients took other drugs of abuse, some patients solely abused Carisoprodol. Withdrawal symptoms have been reported following abrupt cessation of Carisoprodol tablets USP after prolonged use. Reported withdrawal symptoms included insomnia, vomiting, abdominal cramps, headache, tremors, muscle twitching, ataxia, hallucinations, and psychosis. One of Carisoprodol’s metabolites, meprobamate (a controlled substance), may also cause dependence [see Clinical Pharmacology (12.3)].
To reduce the risk of Carisoprodol tablets USP abuse, assess the risk of abuse prior to prescribing. After prescribing, limit the length of treatment to three weeks for the relief of acute musculoskeletal discomfort, keep careful prescription records, monitor for signs of abuse and overdose, and educate patients and their families about abuse and on proper storage and disposal.

Seizures

There have been post-marketing reports of seizures in patients who received Carisoprodol tablets USP. Most of these cases have occurred in the setting of multiple drug overdoses (including drugs of abuse, illegal drugs, and alcohol) [see Overdosage (10)].

Adverse Reactions

Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect rates observed in practice.
The data described below are based on 1387 patients pooled from two double blind, randomized, multicenter, placebo controlled, one-week trials in adult patients with acute, mechanical, lower back pain [see Clinical Studies (14)]. In these studies, patients were treated with 250 mg of Carisoprodol tablets USP, 350 mg of Carisoprodol tablets USP, or placebo three times a day and at bedtime for seven days. The mean age was about 41 years old with 54% females and 46% males and 74 % Caucasian, 16 % Black, 9% Asian, and 2% other.
There were no deaths and there were no serious adverse reactions in these two trials. In these two studies, 2.7%, 2%, and 5.4%, of patients treated with placebo, 250 mg of Carisoprodol tablets USP, and 350 mg of Carisoprodol tablets USP, respectively, discontinued due to adverse events; and 0.5%, 0.5%, and 1.8% of patients treated with placebo, 250 mg of Carisoprodol tablets USP, and 350 mg of Carisoprodol tablets USP, respectively, discontinued due to central nervous system adverse reactions.
Table 1 displays adverse reactions reported with frequencies greater than 2% and more frequently than placebo in patients treated with Carisoprodol tablets USP in the two trials described above.


Table 1. Patients with Adverse Reactions in Controlled Studies
Adverse
Reaction
Placebo
(n=560)
n (%)
Carisoprodol Tablets USP 250 mg
(n=548)
n (%)
Carisoprodol Tablets USP 350 mg
(n=279)
n (%)
Drowsiness
31 (6)
73 (13)
47 (17)
Dizziness
11 (2)
43 (8)
19 (7)
Headache
11 (2)
26 (5)
9 (3)

Post-marketing Experience

The following events have been reported during postapproval use of Carisoprodol tablets USP. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cardiovascular: Tachycardia, postural hypotension, and facial flushing [see Overdosage (10)].
Central Nervous System: Drowsiness, dizziness, vertigo, ataxia, tremor, agitation, irritability, headache, depressive reactions, syncope, insomnia, and seizures [see Overdosage (10)].
Gastrointestinal: Nausea, vomiting, and epigastric discomfort.
Hematologic: Leukopenia, pancytopenia

Drug Interactions

CNS Depressants

The sedative effects of Carisoprodol tablets USP and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) may be additive. Therefore, caution should be exercised with patients who take more than one of these CNS depressants simultaneously. Concomitant use of Carisoprodol tablets USP and meprobamate, a metabolite of Carisoprodol tablets USP, is not recommended [see Warnings and Precautions (5.1)].

CYP2C19 Inhibitors and Inducers

Carisoprodol USP is metabolized in the liver by CYP2C19 to form meprobamate [see Clinical Pharmacology (12.3) ]. Co-administration of CYP2C19 inhibitors, such as omeprazole or fluvoxamine, with Carisoprodol tablets USP could result in increased exposure of Carisoprodol USP and decreased exposure of meprobamate. Co-administration of CYP2C19 inducers, such as rifampin or St. John’s Wort, with Carisoprodol tablets USP could result in decreased exposure of Carisoprodol USP and increased exposure of meprobamate. Low dose aspirin also showed an induction effect on CYP2C19. The full pharmacological impact of these potential alterations of exposures in terms of either efficacy or safety of Carisoprodol tablets USP is unknown.

USE IN SPECIFIC POPULATIONS

Pregnancy: Pregnancy Category C

Pregnancy Category C.
There are no data on the use of Carisoprodol tablets USP during human pregnancy. Animal studies indicate that Carisoprodol USP crosses the placenta and results in adverse effects on fetal growth and postnatal survival. The primary metabolite of Carisoprodol, meprobamate, is an approved anxiolytic. Retrospective, post-marketing studies do not show a consistent association between maternal use of meprobamate and an increased risk for particular congenital malformations.
Teratogenic effects: Animal studies have not adequately evaluated the teratogenic effects of Carisoprodol. There was no increase in the incidence of congenital malformations noted in reproductive studies in rats, rabbits, and mice treated with meprobamate. Retrospective, post-marketing studies of meprobamate during human pregnancy were equivocal for demonstrating an increased risk of congenital malformations following first trimester exposure. Across studies that indicated an increased risk, the types of malformations were inconsistent.
Nonteratogenic effects: In animal studies, Carisoprodol USP reduced fetal weights, postnatal weight gain, and postnatal survival at maternal doses equivalent to 1 to 1.5 times the human dose (based on a body surface area comparison). Rats exposed to meprobamate in-utero showed behavioral alterations that persisted into adulthood. For children exposed to meprobamate in-utero, one study found no adverse effects on mental or motor development or IQ scores. Carisoprodol tablets USP should be used during pregnancy only if the potential benefit justifies the risk to the fetus.


Labor & Delivery


There is no information about the effects of Carisoprodol tablets USP on the mother and the fetus during labor and delivery.

Nursing Mothers

Very limited data in humans show that Carisoprodol USP is present in breast milk and may reach concentrations two to four times the maternal plasma concentrations. In one case report, a breast-fed infant received about 4 to 6% of the maternal daily dose through breast milk and experienced no adverse effects. However, milk production was inadequate and the baby was supplemented with formula. In lactation studies in mice, female pup survival and pup weight at weaning were decreased. This information suggests that maternal use of Carisoprodol tablets USP may lead to reduced or less effective infant feeding (due to sedation) and/or decreased milk production. Caution should be exercised when Carisoprodol tablets USP is administered to a nursing woman.

Pediatric Use

The efficacy, safety, and pharmacokinetics of Carisoprodol tablets USP in pediatric patients less than 16 years of age have not been established.

Geriatric Use

The efficacy, safety, and pharmacokinetics of Carisoprodol tablets USP in patients over 65 years old have not been established.

Renal Impairment

The safety and pharmacokinetics of Carisoprodol tablets USP in patients with renal impairment have not been evaluated. Since Carisoprodol tablets USP is excreted by the kidney, caution should be exercised if Carisoprodol tablets USP is administered to patients with impaired renal function. Carisoprodol USP is dialyzable by hemodialysis and peritoneal dialysis.

Hepatic Impairment

The safety and pharmacokinetics of Carisoprodol tablets USP in patients with hepatic impairment have not been evaluated. Since Carisoprodol tablets USP is metabolized in the liver, caution should be exercised if Carisoprodol tablets USP is administered to patients with impaired hepatic function.

Patients with Reduced CYP2C19 Activity

Patients with reduced CYP2C19 activity have higher exposure to Carisoprodol. Therefore, caution should be exercised in administration of Carisoprodol tablets USP to these patients [see Clinical Pharmacology (12.3)].

Drug Abuse and Dependence

Controlled Substance

Carisoprodol tablets USP contains Carisoprodol USP, a Schedule IV controlled substance. Carisoprodol USP has been subject to abuse, misuse, and criminal diversion for nontherapeutic use [see Warnings and Precautions (5.2)].

Abuse

Abuse of Carisoprodol USP poses a risk of overdosage which may lead to death, CNS and respiratory depression, hypotension, seizures and other disorders  [see Warnings and Precautions (5.2)and Overdosage (10)]. Patients at high risk of Carisoprodol tablets USP abuse may include those with prolonged use of Carisoprodol USP, with a history of drug abuse, or those who use Carisoprodol tablets USP in combination with other abused drugs.

Prescription drug abuse is the intentional non-therapeutic use of a drug, even once, for its rewarding psychological effects. Drug addiction, which develops after repeated drug abuse, is characterized by a strong desire to take a drug despite harmful consequences, difficulty in controlling its use, giving a higher priority to drug use than to obligations, increased tolerance, and sometimes physical withdrawal. Drug abuse and drug addiction are separate and distinct from physical dependence and tolerance (for example, abuse or addiction may not be accompanied by tolerance or physical dependence)[see Drug Abuse and Dependence (9.3)].

Dependence

Tolerance is when a patient’s reaction to a specific dosage and concentration is progressively reduced in the absence of disease progression, requiring an increase in the dosage to maintain the same. Physical dependence is characterized by withdrawal symptoms after abrupt discontinuation or a significant dose reduction of a drug. Both tolerance and physical dependence have been reported with the prolonged use of Carisoprodol tablets USP. Reported withdrawal symptoms with Carisoprodol tablets USP include insomnia, vomiting, abdominal cramps, headache, tremors, muscle twitching, anxiety, ataxia, hallucinations, and psychosis. Instruct patients taking large doses of Carisoprodol tablets USP or those taking the drug for a prolonged time to not abruptly stop Carisoprodol tablets USP [see  Warnings and Precautions (5.2)].

Overdosage

Overdosage of Carisoprodol tablets USP commonly produces CNS depression. Death, coma, respiratory depression, hypotension, seizures, delirium, hallucinations, dystonic reactions, nystagmus, blurred vision, mydriasis, euphoria, muscular incoordination, rigidity, and/or headache have been reported with Carisoprodol tablets USP overdosage. Serotonin syndrome has been reported with Carisoprodol USP intoxication. Many of the Carisoprodol USP overdoses have occurred in the setting of multiple drug overdoses (including drugs of abuse, illegal drugs, and alcohol). The effects of an overdose of Carisoprodol tablets USP and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) can be additive even when one of the drugs has been taken in the recommended dosage. Fatal accidental and non-accidental overdoses of Carisoprodol tablets USP have been reported alone or in combination with CNS depressants.
Treatment of Overdosage: Basic life support measures should be instituted as dictated by the clinical presentation of the Carisoprodol tablets USP overdose. Vomiting should not be induced because of the risk of CNS and respiratory depression, and subsequent aspiration.. Circulatory support should be administered with volume infusion and vasopressor agents if needed. Seizures should be treated with intravenous benzodiazepines and the reoccurrence of seizures may be treated with phenobarbital. In cases of severe CNS depression, airway protective reflexes may be compromised and tracheal intubation should be considered for airway protection and respiratory support.
For decontamination in cases of severe toxicity, activated charcoal should be considered in a hospital setting in patients with large overdoses who present early and are not demonstrating CNS depression and can protect their airway.
For more information on the management of an overdose of Carisoprodol tablets USP, contact a Poison Control Center.

Carisoprodol Description

Carisoprodol tablets USP are available as 250 mg and 350 mg circular shaped, white to off white, biconvex tablets. Carisoprodol USP is a white, crystalline powder, having a mild, characteristic odor and a bitter taste. It is slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH. Carisoprodol USP is present as a racemic mixture. Chemically, Carisoprodol USP is N-isopropyl-2-methyl-2-propyl-1,3-propanediol dicarbamate and the molecular formula is C12H24N2O4, with a molecular weight of 260.33. The structural formula is:



Other ingredients in the Carisoprodol tablets USP drug product include microcrystalline cellulose, croscarmellose sodium, povidone, magnesium stearate and maize starch.

Carisoprodol - Clinical Pharmacology

Mechanism of Action

The mechanism of action of Carisoprodol USP in relieving discomfort associated with acute painful musculoskeletal conditions has not been clearly identified.
In animal studies, muscle relaxation induced by Carisoprodol USP is associated with altered interneuronal activity in the spinal cord and in the descending reticular formation of the brain.


Pharmacodynamics

Carisoprodol USP is a centrally acting skeletal muscle relaxant that does not directly relax skeletal muscles.
A metabolite of Carisoprodol, meprobamate, has anxiolytic and sedative properties. The degree to which these properties of meprobamate contribute to the safety and efficacy of Carisoprodol tablets USP is unknown.

Pharmacokinetics

The pharmacokinetics of Carisoprodol USP and its metabolite meprobamate were studied in a crossover study of 24 healthy subjects (12 male and 12 female) who received single doses of 250 mg and 350 mg Carisoprodol tablets USP (see Table 2). The exposure of Carisoprodol USP and meprobamate was dose proportional between the 250 mg and 350 mg doses. The Cmax of meprobamate was 2.5 ± 0.5 mcg/mL (mean ± SD) after administration of a single 350 mg dose of Carisoprodol tablets USP, which is approximately 30% of the Cmax of meprobamate (approximately 8 mcg /mL) after administration of a single 400 mg dose of meprobamate.

Table 2. Pharmacokinetic Parameters of Carisoprodol USP and Meprobamate
 (Mean ± SD, n=24)
 
250 mg Carisoprodol Tablets USP
350 mg Carisoprodol Tablets USP
Carisoprodol
Cmax (mcg/mL)
1.2 ± 0.5
1.8 ± 1.0
AUCinf (mcg*hr/mL)
4.5 ± 3.1
7.0 ± 5.0
Tmax (hr)
1.5 ± 0.8
1.7 ± 0.8
T1/2 (hr)
1.7 ± 0.5
2.0 ± 0.5
Meprobamate
Cmax (mcg/mL)
1.8 ± 0.3
2.5 ± 0.5
AUCinf (mcg*hr/mL)
32 ± 6.2
46 ± 9.0
Tmax (hr)
3.6 ± 1.7
4.5 ± 1.9
T1/2 (hr)
9.7 ± 1.7
9.6 ± 1.5

Absorption: Absolute bioavailability of Carisoprodol USP has not been determined. The mean time to peak plasma concentrations (Tmax) of Carisoprodol USP was approximately 1.5 to 2 hours. Co-administration of a high-fat meal with Carisoprodol USP (350 mg tablet) had no effect on the pharmacokinetics of Carisoprodol. Therefore, Carisoprodol tablets USP may be administered with or without food.
Metabolism: The major pathway of Carisoprodol USP metabolism is via the liver by cytochrome enzyme CYP2C19 to form meprobamate. This enzyme exhibits genetic polymorphism (see Patients with Reduced CYP2C19 Activity below).
Elimination: Carisoprodol USP is eliminated by both renal and non-renal routes with a terminal elimination half-life of approximately 2 hours. The half-life of meprobamate is approximately 10 hours.
Gender: Exposure of Carisoprodol USP is higher in female than in male subjects (approximately 30 to 50% on a weight adjusted basis). Overall exposure of meprobamate is comparable between female and male subjects.
Patients with Reduced CYP2C19 Activity: Carisoprodol tablets USP should be used with caution in patients with reduced CYP2C19 activity. Published studies indicate that patients who are poor CYP2C19 metabolizers have a 4-fold increase in exposure to Carisoprodol, and concomitant 50% reduced exposure to meprobamate compared to normal CYP2C19 metabolizers. The prevalence of poor metabolizers in Caucasians and African Americans is approximately 3 to 5% and in Asians is approximately 15 to 20%.


Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long term studies in animals have not been performed to evaluate the carcinogenic potential of Carisoprodol.
Carisoprodol tablets USP was not formally evaluated for genotoxicity. In published studies, Carisoprodol USP was mutagenic in the in vitro mouse lymphoma cell assay in the absence of metabolizing enzymes, but was not mutagenic in the presence of metabolizing enzymes. Carisoprodol USP was clastogenic in the in vitro chromosomal aberration assay using Chinese hamster ovary cells with or without the presence of metabolizing enzymes. Other types of genotoxic tests resulted in negative findings. Carisoprodol USP was not mutagenic in the Ames reverse mutation assay using S. typhimurium strains with or without metabolizing enzymes, and was not clastogenic in an in vivo mouse micronucleus assay of circulating blood cells.
Carisoprodol tablets USP was not formally evaluated for effects on fertility. Published reproductive studies of Carisoprodol USP in mice found no alteration in fertility although an alteration in reproductive cycles characterized by a greater time spent in estrus was observed at a Carisoprodol USP dose of 1200 mg/kg/day. In a 13-week toxicology study that did not determine fertility, mouse testes weight and sperm motility were reduced at a dose of 1200 mg/kg/day. In both studies, the no effect level was 750 mg/kg/day, corresponding to approximately 2.6 times the human equivalent dosage of 350 mg four times a day, based on a body surface area comparison.
The significance of these findings for human fertility is not known.

Clinical Studies

The safety and efficacy of Carisoprodol tablets USP for the relief of acute, idiopathic mechanical low back pain was evaluated in two, 7-day, double blind, randomized, multicenter, placebo controlled, U.S. trials (Studies 1 and 2). Patients had to be 18 to 65 years old and had to have acute back pain (≤ 3 days of duration) to be included in the trials. Patients with chronic back pain; at increased risk for vertebral fracture (e.g., history of osteoporosis); with a history of spinal pathology (e.g., herniated nucleus pulposis, spondylolisthesis or spinal stenosis); with inflammatory back pain, or with evidence of a neurologic deficit were excluded from participation. Concomitant use of analgesics (e.g., acetaminophen, NSAIDs, tramadol, opioid agonists), other muscle relaxants, botulinum toxin, sedatives (e.g., barbiturates, benzodiazepines, promethazine hydrochloride), and anti-epileptic drugs was prohibited.
In Study 1, patients were randomized to one of three treatment groups (i.e., Carisoprodol tablets USP 250 mg, Carisoprodol tablets USP 350 mg, or placebo) and in Study 2 patients were randomized to two treatment groups (i.e., Carisoprodol tablets USP 250 mg or placebo). In both studies, patients received study medication three times a day and at bedtime for seven days.
The primary endpoints were the relief from starting backache and the global impression of change, as reported by patients, on Study Day 3. Both endpoints were scored on a 5-point rating scale from 0 (worst outcome) to 4 (best outcome) in both studies. The primary statistical comparison was between the Carisoprodol tablets USP 250 mg and placebo groups in both studies.
The proportion of patients who used concomitant acetaminophen, NSAIDs, tramadol, opioid agonists, other muscle relaxants, and benzodiazepines was similar in the treatment groups.
The results for the primary efficacy evaluations in the acute, low back pain studies are presented in Table 3.



Table 3. Results of the Primary Efficacy Endpointsa in Studies 1 and 2
Study
Parameter
Placebo
Carisoprodol Tablets USP
250 mg
Carisoprodol Tablets USP
350 mg
1
Number of Patients
n=269
n=264
n=273
Relief from StartingBackache, Mean (SE) b
1.4 (0.1)
1.8 (0.1)
1.8 (0.1)
 
      Difference between Carisoprodol tablets USP
      and Placebo, Mean (SE) b (95% CI)
 
0.4
(0.2, 0.5)
0.4
(0.2, 0.6)
 
Global Impression of Change, Mean (SE) b
1.9 (0.1)
2.2 (0.1)
2.2 (0.1)
 
      Difference between Carisoprodol tablets USP
      and Placebo, Mean (SE) b (95% CI)
 
0.2
(0.1, 0.4)
0.3
(0.1, 0.4)
 
2
Number of Patients
n=278
n=269
 
Relief from StartingBackache, Mean (SE) b
1.1 (0.1)
1.8 (0.1)
 
 
      Difference between Carisoprodol tablets USP
      and Placebo, Mean (SE) b (95% CI)
 
0.7
(0.5, 0.9)
 
 
Global Impression of Change, Mean (SE) b
1.7 (0.1)
2.2 (0.1)
 
 
      Difference between Carisoprodol tablets USP
      and Placebo, Mean (SE) b (95% CI)
 
0.5
(0.4, 0.7)
 
 
a The primary efficacy endpoints (Relief from Starting Backache and Global Impression of Change) were assessed by the patients on Study Day 3. These endpoints were scored on a 5-point rating scale from 0 (worst outcome) to 4 (best outcome).
b Mean is the least squared mean and SE is the standard error of the mean. The ANOVA model was used for the primary statistical comparison between the Carisoprodol tablets USP 250 mg and placebo groups.


Patients treated with Carisoprodol tablets USP experienced improvement in function as measured by the Roland-Morris Disability Questionnaire (RMDQ) score on Days 3 and 7.

How Supplied/Storage and Handling

Carisoprodol Tablets USP, 250 mg: circular shaped, biconvex, white to off white colored, uncoated tablets debossed  "S" and "434" on one side and plain on the other side, available as follows

NDC 42543-434-01: Bottles of 100 tablets
NDC 42543-434-05: Bottles of 500 tablets
NDC 42543-434-10: Bottles of 1000 tablets                                                                                                                                                                         
                                                                                                  
Carisoprodol Tablets USP, 350 mg: circular shaped, biconvex, white to off white colored, uncoated tablets debossed  "S" and "435" on one side and plain on the other side, available as follows
                                                                                                                                        
NDC 42543-435-01: Bottles of 100 tablets
NDC 42543-435-05: Bottles of 500 tablets
NDC 42543-435-10: Bottles of 1000 tablets
                                                                                                                                                             

Storage:
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].

Patient Counseling Information

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

Sedation

Patients should be advised 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

Patients should be advised 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

Patients should be advised 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.

Manufactured for:
Vensun Pharmaceuticals, Inc.
Yardley, PA 19067.

Manufactured by:                                                                                                                                       
Shasun Pharmaceuticals Limited                                                                                                                                                                                                                                                                       
Puducherry, India.                                                                                                                                           
Rev. 00, November 2015

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label  - Principle Display Panel - 100 - Count Bottle, 250 mg Tablets

NDC 42543-434-01        
100 Tablets
Carisoprodol Tablets,USP
250 mg
CIV 
Rx only
VENSUNPHARMACEUTICALS,  INC.


Carisoprodol   IMMEDIATE RELEASE
Carisoprodol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:42543-434
Route of Administration ORAL DEA Schedule CIV    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Carisoprodol (Carisoprodol) Carisoprodol 250 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE  
CROSCARMELLOSE SODIUM  
POVIDONE  
MAGNESIUM STEARATE  
STARCH, CORN  
Product Characteristics
Color WHITE Score no score
Shape ROUND (circular shaped) Size 10mm
Flavor Imprint Code S;434
Contains         
Packaging
# Item Code Package Description
1 NDC:42543-434-01 100 TABLET in 1 BOTTLE
2 NDC:42543-434-05 500 TABLET in 1 BOTTLE
3 NDC:42543-434-10 1000 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205513 11/20/2015
Labeler - Vensun Pharmaceuticals, Inc (078310501)
Establishment
Name Address ID/FEI Operations
Shasun Pharmaceuticals Limited 915786829 MANUFACTURE(42543-434)
Revised: 12/2015
 
Vensun Pharmaceuticals, Inc
Hide