Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Chlorzoxazone tablets, USP, 250 mg are supplied as white to off-white, capsule shaped, uncoated tablets debossed with “C15” on one side and plain on other side. Bottles of 30 Tablets NDC 31722-974-30 Bottles of 60 Tablets NDC 31722-974-60 Bottles of 100 Tablets NDC 31722-974-01 Bottles of 500 Tablets NDC 31722-974-05 Bottles of 1000 Tablets NDC 31722-974-10 Dispense in tight container as defined in the USP. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854. Manufactured by: CorePharma, LLC. 215 Wood Ave, Middlesex, NJ 08846 Revised: 02/2022 40033 logo; PRINCIPAL DISPLAY PANEL - 250 mg BOTTLE LABEL Camber Pharmaceuticals, Inc. NDC 31722- 974 -60 Chlorzoxazone tablets, USP, 250 mg Rx only 60 Tablets containerlabel60s
- HOW SUPPLIED Chlorzoxazone tablets, USP, 250 mg are supplied as white to off-white, capsule shaped, uncoated tablets debossed with “C15” on one side and plain on other side. Bottles of 30 Tablets NDC 31722-974-30 Bottles of 60 Tablets NDC 31722-974-60 Bottles of 100 Tablets NDC 31722-974-01 Bottles of 500 Tablets NDC 31722-974-05 Bottles of 1000 Tablets NDC 31722-974-10 Dispense in tight container as defined in the USP. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854. Manufactured by: CorePharma, LLC. 215 Wood Ave, Middlesex, NJ 08846 Revised: 02/2022 40033 logo
- PRINCIPAL DISPLAY PANEL - 250 mg BOTTLE LABEL Camber Pharmaceuticals, Inc. NDC 31722- 974 -60 Chlorzoxazone tablets, USP, 250 mg Rx only 60 Tablets containerlabel60s
Overview
Each tablet contains: Chlorzoxazone, USP*…………… 250 mg *5-Chloro-2-benzoxazolinone Structural Formula: Molecular Formula: C 7 H 4 ClNO 2 Molecular Weight: 169.57 Chlorzoxazone, USP is a white to off-white crystalline powder. Chlorzoxazone is soluble in alkali hydroxides and sparingly soluble in methanol. Inactive ingredients: anhydrous lactose, croscarmellose sodium, docusate sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize) and sodium benzoate. FDA approved dissolution test specifications differ from USP chemstructure
Indications & Usage
Chlorzoxazone is 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.
Dosage & Administration
Usual Adult Dosage: One tablet (250 mg) three or four times daily. Initial dosage for painful musculoskeletal conditions should be two tablets (500 mg) three or four times daily. If adequate response is not obtained with this dose, it may be increased to three tablets (750 mg) three or four times daily. As improvement occurs dosage can usually be reduced.
Warnings & Precautions
WARNINGS Serious (including fatal) hepatocellular toxicity has been reported rarely in patients receiving chlorzoxazone. The mechanism is unknown but appears to be idiosyncratic and unpredictable. Factors predisposing patients to this rare event are not known. Patients should be instructed to report early signs and/or symptoms of hepatotoxicity such as fever, rash, anorexia, nausea, vomiting, fatigue, right upper quadrant pain, dark urine, or jaundice. Chlorzoxazone should be discontinued immediately and a physician consulted if any of these signs or symptoms develop. Chlorzoxazone use should also be discontinued if a patient develops abnormal liver enzymes (e.g., AST, ALT, alkaline phosphatase and bilirubin). The concomitant use of alcohol or other central nervous system depressants may have an additive effect. Usage in Pregnancy: The safe use of chlorzoxazone has not been established with respect to the possible adverse effects upon fetal development. Therefore, it should be used in women of childbearing potential only when, in the judgment of the physician, the potential benefits outweigh the possible risks.
Contraindications
Chlorzoxazone is contraindicated in patients with known intolerance to the drug.
Adverse Reactions
After extensive clinical use of chlorzoxazone-containing products, it is apparent that the product is well tolerated and seldom produces undesirable side effects. Occasional patients may develop gastrointestinal disturbances. 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. To report SUSPECTED ADVERSE REACTIONS, contact Camber Pharmaceuticals, Inc. at 1-866-495-1995 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch for voluntary reporting of adverse reactions.
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