Drug Facts
Composition & Profile
Identifiers & Packaging
How Supplied Methocarbamol Tablets USP, 500 mg are light orange colored, round, film-coated tablets, engraved with 'B134' on one side and scored on the other side. They are supplied as follows: Bottles of 60 tablets: NDC 80425-0138-01 Bottles of 90 tablets: NDC: 80425-0138-02 Store at controlled room temperature, between 20°C and 25°C (68°F and 77°F). Dispense in tight container. Manufactured for Beximco Pharmaceuticals USA Inc. 4110 Regal Oaks Drive, P.O. Box 1060 Suwanee, GA 30024, USA Manufactured by BEXIMCO PHARMACEUTICALS LTD. 126, Kathaldia, Tongi, Gazipur, 1711, Bangladesh Distributed by: Bayshore Pharmaceuticals LLC Short Hills, NJ 07078 Distributed by: Advanced Rx Pharmacy of Tennessee LLC, Nashville, TN, 37211 Last revised on 12/2017 5001397 111217; Principal Display Panel label 1 label 2
- How Supplied Methocarbamol Tablets USP, 500 mg are light orange colored, round, film-coated tablets, engraved with 'B134' on one side and scored on the other side. They are supplied as follows: Bottles of 60 tablets: NDC 80425-0138-01 Bottles of 90 tablets: NDC: 80425-0138-02 Store at controlled room temperature, between 20°C and 25°C (68°F and 77°F). Dispense in tight container. Manufactured for Beximco Pharmaceuticals USA Inc. 4110 Regal Oaks Drive, P.O. Box 1060 Suwanee, GA 30024, USA Manufactured by BEXIMCO PHARMACEUTICALS LTD. 126, Kathaldia, Tongi, Gazipur, 1711, Bangladesh Distributed by: Bayshore Pharmaceuticals LLC Short Hills, NJ 07078 Distributed by: Advanced Rx Pharmacy of Tennessee LLC, Nashville, TN, 37211 Last revised on 12/2017 5001397 111217
- Principal Display Panel label 1 label 2
Overview
Methocarbamol Tablets USP, 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 C11H15NO5. 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. Methocarbamol Tablets USP, 500 mg is available as a light orange colored, round, film-coated tablets, engraved with 'B134' on one side and scored on the other side, containing 500 mg of methocarbamol, USP for oral administration. The inactive ingredients present are corn starch, low substituted hydroxypropyl cellulose, hydroxyprolyl cellulose, sodium starch glycolate, povidone, sodium lauryl sulfate, colloidal silicon dioxide, stearic acid, magnesium stearate, and purified water. Methocarbamol Tablets USP, 500 mg contains Opadry 13H530000 (Orange) (hypromellose, titanium dioxide, propylene glycol, FD&C yellow #6/Sunset Yellow FCF Aluminum Lake, polysorbate 20) as coating material. Methocarbamol Tablets USP, 750 mg is available as an orange colored, capsule shaped, film coated tablets, engraved with 'B135' on one side and plain on the other side, containing 750 mg of methocarbamol, USP for oral administration. It contains Opadry 13H530001 (Orange) as coating material. The inactive ingredients present are corn starch, low substituted hydroxypropyl cellulose, hydroxyprolyl cellulose, sodium starch glycolate, povidone, sodium lauryl sulfate, colloidal silicon dioxide, stearic acid, magnesium stearate, and purified water. Methocarbamol Tablets USP, 750 mg contain Opadry 13H530001 (Orange) (hypromellose, titanium dioxide, propylene glycol, D&C Yellow #10 Aluminum Lake, FD&C yellow #6/Sunset Yellow FCC Aluminum Lake, polysorbate 20) as coating Structure
Indications & Usage
Section Methocarbamol Tablets USP, 500 mg and 750 mg 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 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
DOSAGE AND ADMINISTRATION Methocarbamol Tablets USP, 500 mg – Adults: Initial dosage: 3 tablets q.i.d. Maintenance dosage: 2 tablets q.i.d. Methocarbamol Tablets USP, 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 USP, 500 mg or 750 mg should be cautioned about combined effects with alcohol and other CNS depressants. Safe use of Methocarbamol Tablets USP, 500 mg and 750 mg 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 USP, 500 mg and 750 mg 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 Tablets USP, 500 mg and 750 mg are 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.
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