Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Methocarbamol Tablets, USP 500 mg — white, round, convex face, debossed “611” over bisect and “O” below bisect on one side and plain on the reverse side. Available in: Bottles of 90, NDC number 69584-611-09 bottles of 100, NDC number 69584-611-10 bottles of 500, NDC number 69584-611-50 bottles of 1000, NDC number 69584-611-90 Methocarbamol Tablets, USP 750 mg — white, capsule shape, convex face, debossed “612” on one side and debossed “O” on the reverse side. Available in: bottles of 90, NDC number 69584-612-09 bottles of 100, NDC number 69584-612-10 bottles of 500, NDC number 69584-612-50 bottles of 1000, NDC number 69584-612-90 Store at 20°– 25°C (68°– 77°F) [See USP Controlled Room Temperature]. Dispense in tight container. For more information, call Oxford Pharmaceuticals, LLC at 1-844-508‑1455, 8:00 AM to 4.30 PM ET, Monday – Friday Manufactured by: OXFORD PHARMACEUTICALS Birmingham, AL 35211 8200004 Rev 12/20 R01; Bottle of 60 242
- HOW SUPPLIED Methocarbamol Tablets, USP 500 mg — white, round, convex face, debossed “611” over bisect and “O” below bisect on one side and plain on the reverse side. Available in: Bottles of 90, NDC number 69584-611-09 bottles of 100, NDC number 69584-611-10 bottles of 500, NDC number 69584-611-50 bottles of 1000, NDC number 69584-611-90 Methocarbamol Tablets, USP 750 mg — white, capsule shape, convex face, debossed “612” on one side and debossed “O” on the reverse side. Available in: bottles of 90, NDC number 69584-612-09 bottles of 100, NDC number 69584-612-10 bottles of 500, NDC number 69584-612-50 bottles of 1000, NDC number 69584-612-90 Store at 20°– 25°C (68°– 77°F) [See USP Controlled Room Temperature]. Dispense in tight container. For more information, call Oxford Pharmaceuticals, LLC at 1-844-508‑1455, 8:00 AM to 4.30 PM ET, Monday – Friday Manufactured by: OXFORD PHARMACEUTICALS Birmingham, AL 35211 8200004 Rev 12/20 R01
- Bottle of 60 242
Overview
Methocarbamol Tablets, USP, 500 mg and 750 mg, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 3-(2-methoxyphenoxy)-1, 2-propanediol 1-carbamate and has the empirical formula C 11 H 15 NO 5 . Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n -hexane. Each tablet, for oral administration, contains either 500 mg or 750 mg of methocarbamol, USP. The inactive ingredients present are colloidal silicon dioxide, magnesium stearate, povidone, pregelatinized corn starch, purified water, sodium starch glycolate, and stearic acid. str
Indications & Usage
Methocarbamol 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 methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.
Dosage & Administration
Methocarbamol, 500 mg — Adults: Initial dosage: 3 tablets q.i.d. Maintenance dosage: 2 tablets q.i.d. Methocarbamol, 750 mg — Adults: Initial dosage: 2 tablets q.i.d. Maintenance dosage: 1 tablet q.4h. or 2 tablets t.i.d. Six grams a day are recommended for the first 48 to 72 hours of treatment. (For severe conditions 8 grams a day may be administered). Thereafter, the dosage can usually be reduced to approximately 4 grams a day.
Warnings & Precautions
WARNINGS Since methocarbamol may possess a general CNS depressant effect, patients receiving methocarbamol tablets should be cautioned about combined effects with alcohol and other CNS depressants. Safe use of methocarbamol has not been established with regard to possible adverse effects upon fetal development. There have been reports of fetal and congenital abnormalities following in utero exposure to methocarbamol. Therefore, methocarbamol tablets should not be used in women who are or may become pregnant and particularly during early pregnancy unless in the judgment of the physician the potential benefits outweigh the possible hazards (see PRECAUTIONS, Pregnancy ) . Use in Activities Requiring Mental Alertness Methocarbamol may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle. Patients should be cautioned about operating machinery, including automobiles, until they are reasonably certain that methocarbamol therapy does not adversely affect their ability to engage in such activities.
Contraindications
Methocarbamol is contraindicated in patients hypersensitive to methocarbamol or to any of the tablet components.
Adverse Reactions
Adverse reactions reported coincident with the administration of methocarbamol include: Body as a whole: Anaphylactic reaction, angioneurotic edema, fever, headache Cardiovascular system: Bradycardia, flushing, hypotension, syncope, thrombophlebitis Digestive system: Dyspepsia, jaundice (including cholestatic jaundice), nausea and vomiting Hemic and lymphatic system: Leukopenia Immune system: Hypersensitivity reactions Nervous system: Amnesia, confusion, diplopia, dizziness or lightheadedness, drowsiness, insomnia, mild muscular incoordination, nystagmus, sedation, seizures (including grand mal), vertigo Skin and special senses: Blurred vision, conjunctivitis, nasal congestion, metallic taste, pruritus, rash, urticaria
Drug Interactions
See WARNINGS and PRECAUTIONS for interaction with CNS drugs and alcohol. Methocarbamol may inhibit the effect of pyridostigmine bromide. Therefore, methocarbamol should be used with caution in patients with myasthenia gravis receiving anticholinesterase agents.
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