Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Methocarbamol Tablets USP, 500 mg — Orange, film coated, round concave tablets with one side debossed 'AP212', the other side bisected. They are supplied as follows: Bottles of 100, NDC 35561-212-12 Bottles of 500, NDC 35561-212-13 Methocarbamol Tablets USP, 750 mg — Yellow, film coated, modified capsule shaped tablets; one side debossed 'AP211' and other side blank. They are supplied as follows: Bottles of 100, NDC 35561-211-1 Bottles of 500, NDC 35561-211-13 Methocarbamol Tablets USP, 1000 mg — Orange, film coated, oblong-shaped tablets; one side debossed 'AP349' and other side biscted. They are supplied as follows: Bottles of 100, NDC 35561-349-12 Bottles of 500, NDC 35561-349-13 Store at controlled room temperature, between 20° to 25°C (68° to 77°F). Dispense in tight container. LBL136 REV050622 revised: May 2022 Manufactured by: AustarPharma, LLC 18 Mayfield Ave Edison, NJ 08837, USA; Principal Display Panel - 500mg 500counts NDC: 35561-212-13 Methocarbamol 500mg 500 tablet (s) RX only Austar-500mg500ct; Principal Display Panel - 500mg 100 counts NDC: 35561-212-12 Methocarbamol 500mg 100 tablet (s) RX only Austar-500mg100ct; Principal Display Panel - 750mg 100counts NDC: 35561-211-12 Methocarbamol 750mg 100 tablet (s) RX only Austar-750mg100ct; Principal Display Panel - 750mg 500counts NDC: 35561-211-13 Methocarbamol 750mg 500tablet (s) RX only Austar-750mg500ct; Principal Display Pane - 1000 mg 100 counts NDC: 35561-349-12 Methocarbamol 1000mg 100 tablet(s) Rx Only 1000 mg-100 count; Principal Display Panel - 1000 mg 500 counts NDC: 35561-349-13 Methocarbamol 1000 mg 5000 tablets RX only 1000 mg 500 counts
- HOW SUPPLIED Methocarbamol Tablets USP, 500 mg — Orange, film coated, round concave tablets with one side debossed 'AP212', the other side bisected. They are supplied as follows: Bottles of 100, NDC 35561-212-12 Bottles of 500, NDC 35561-212-13 Methocarbamol Tablets USP, 750 mg — Yellow, film coated, modified capsule shaped tablets; one side debossed 'AP211' and other side blank. They are supplied as follows: Bottles of 100, NDC 35561-211-1 Bottles of 500, NDC 35561-211-13 Methocarbamol Tablets USP, 1000 mg — Orange, film coated, oblong-shaped tablets; one side debossed 'AP349' and other side biscted. They are supplied as follows: Bottles of 100, NDC 35561-349-12 Bottles of 500, NDC 35561-349-13 Store at controlled room temperature, between 20° to 25°C (68° to 77°F). Dispense in tight container. LBL136 REV050622 revised: May 2022 Manufactured by: AustarPharma, LLC 18 Mayfield Ave Edison, NJ 08837, USA
- Principal Display Panel - 500mg 500counts NDC: 35561-212-13 Methocarbamol 500mg 500 tablet (s) RX only Austar-500mg500ct
- Principal Display Panel - 500mg 100 counts NDC: 35561-212-12 Methocarbamol 500mg 100 tablet (s) RX only Austar-500mg100ct
- Principal Display Panel - 750mg 100counts NDC: 35561-211-12 Methocarbamol 750mg 100 tablet (s) RX only Austar-750mg100ct
- Principal Display Panel - 750mg 500counts NDC: 35561-211-13 Methocarbamol 750mg 500tablet (s) RX only Austar-750mg500ct
- Principal Display Pane - 1000 mg 100 counts NDC: 35561-349-12 Methocarbamol 1000mg 100 tablet(s) Rx Only 1000 mg-100 count
- Principal Display Panel - 1000 mg 500 counts NDC: 35561-349-13 Methocarbamol 1000 mg 5000 tablets RX only 1000 mg 500 counts
Overview
Methocarbamol Tablets USP, 500 mg, 750 mg, and 1000 mg, a carbamate derivative of gualfenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is a 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 Tablet, 500 mg is available as an orange, film coated, round concave tablet containing 500 mg of methocarbamol, USP for oral administration. The inactive ingredients present are microcrystalline cellulose, croscarmellose sodium, FD&C Yellow 6 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, triacetin, titanium dioxide. Methocarbamol Tablet, 750 mg is available as a yellow, film coated, modified capsule shaped tablet containing 750 mg of methocarbamol, USP for oral administration. The inactive ingredients present are microcrystalline cellulose, croscarmellose sodium, iron oxide yellow, iron oxide red, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, triacetin, titanium dioxide. Methocarbamol tablet, 1000 mg is available as an orange, film coated, oblong-shaped tablet containing 1000 mg of methocarbamol, USP for oral administration. The inactive ingredients present in methocarbamol tablets 1000 mg are same as those present in methocarbamol tablets 500 mg. Methocarbamol Structure
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 4 times daily. Maintenance dosage: 2 tablets 4 times daily Methocarbamol, 750 mg — Adults: Initial dosage: 2 tablets 4 times daily. Maintenance dosage: 1 tablet 4 times daily or 2 tablets 3 times daily Methocarbamol, 1000 mg — Adults: Initial dosage: 1 ½ tablets 4 times daily. Maintenance dosage: 1 tablets 4 times daily 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).
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 To report SUSPECTED ADVERSE REACTIONS, contact AustarPharma LLC at 1-844-375-5410 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
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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