DailyMed Label: Parafon DSC

DailyMed Label: Parafon DSC

2010

DailyMed Prescription

Parafon DSC

Chlorzoxazone

Keltman Pharmaceuticals Inc.

NDC: 68387-375

NDC: 68387-375

Each caplet (round shaped tablet) contains: Chlorzoxazone                    500 mg Inactive ingredients: Colloidal Silicon Dioxide, Croscarmellose Sodium, docusate Sodium, lactose anhydrous, magnesium stearate, microcrystalline cellulose, sodium benzoate, D&C yellow No. 10 alum. Lake, FD&C blue no. 1 alum. Lake HT STRUCTURAL FORMULA

Chlorzoxazone tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Chlorzoxazone does not directly relax tense skeletal muscles in man.

One caplet three or four times daily. If adequate response is not obtained with this dose, it may be increased to 1 ½ caplets (750 mg) three or four times daily. As improvement occurs dosage can usually be reduced.

Chlorzoxazone tablets are contraindicated in patients with known intolerance to the drug.

Chlorzoxazone should be used with caution in patients with known allergies or with a history of allergic reactions to drugs. If a sensitivity reaction occurs such as urticaria, redness, or itching of the skin, the drug should be stopped. If any symptoms suggestive of liver dysfunction are observed, the drug should be discontinued.

Chlorzoxazone containing products are usually well tolerated. It is possible in rare instances that chlorzoxazone may have been associated with gastrointestinal bleeding. Drowsiness, dizziness, lightheadedness, malaise, or overstimulation may be noted by an occasional patient. Rarely, allergic-type skin rashes, petechiae, or ecchymoses may develop during treatment. Angioneurotic edema or anaphylactic reactions are extremely rare. There is no evidence that the drug will cause renal damage. Rarely, a patient may note discoloration of the urine resulting from a phenolic metabolite of chlorzoxazone. This finding is of no known clinical significance.

Chlorzoxazone tablets 500 mg Tablets, (round shaped tablet, light green, imprinted "555/585" and "Barr" scored). NDC 68387-375-90, bottles of 90 NDC 68387-375-30, bottles of 30 Dispense in tight container as defined in the USP/NF. Store at controlled room temperature (15°–30°C, 59°–86°F). Manufactured for: Keltman Pharmaceuticals Inc. 1 Lakeland Square, Suite A Flowood, Ms 39232 R4

Chlorzoxazone is a centrally-acting agent for painful musculoskeletal conditions. Data available from animal experiments as well as human study indicate that chlorzoxazone acts primarily at the level of the spinal cord and subcortical areas of the brain where it inhibits multisynaptic reflex arcs involved in producing and maintaining skeletal muscle spasm of varied etiology. The clinical result is a reduction of the skeletal muscle spasm with relief of pain and increased mobility of the involved muscles. Blood levels of chlorzoxazone can be detected in people during the first 30 minutes and peak levels may be reached, in the majority of the subjects, in about 1 to 2 hours after oral administration of chlorzoxazone. Chlorzoxazone is rapidly metabolized and is excreted in the urine, primarily in a conjugated form as the glucuronide. Less than one percent of a dose of chlorzoxazone is excreted unchanged in the urine in 24 hours.

Package Label - Principal Display Panel – 90-count Bottle, 500 mg Tablets NDC 68387-375-90 Rx Only chlorzoxazone Tablets