PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Methocarbamol Oral Tablet 500 MG #100

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DESCRIPTION SECTION

DESCRIPTION

Methocarbamol tablets, USP, a carbamate derivative of guaifenesin, are a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties.

The chemical name of methocarbamol is 3-(2-meth-oxyphenoxy)-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 are available as 500 mg and 750 mg tablets for oral administration. Methocarbamol tablets, USP 500 mg and 750 mg contain the following inactive ingredients: povidone, sodium starch glycolate and magnesium stearate.

PHARMACOKINETICS SECTION

Pharmacokinetics

In healthy volunteers, the plasma clearance of methocarbamol ranges between 0.20 and 0.80 L/h/kg, the mean plasma elimination half-life ranges between 1 and 2 hours, and the plasma protein binding ranges between 46% and 50%.

Methocarbamol is metabolized via dealkylation and hydroxylation. Conjugation of methocarbamol also is likely. Essentially all methocarbamol metabolites are eliminated in the urine. Small amounts of unchanged methocarbamol also are excreted in the urine.

CLINICAL PHARMACOLOGY SECTION

CLINICAL PHARMACOLOGY

The mechanism of action of methocarbamol in humans has not been established, but may be due to general central nervous system (CNS) depression. It has no direct action on the contractile mechanism of striated muscle, the motor end plate or the nerve fiber.

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INDICATIONS & USAGE SECTION

INDICATIONS AND USAGE

Methocarbamol tablets, USP 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 SECTION

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.

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CONTRAINDICATIONS SECTION

CONTRAINDICATIONS

Methocarbamol tablets, USP are contraindicated in patients hypersensitive to methocarbamol or to any of the tablet components.

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HOW SUPPLIED SECTION

HOW SUPPLIED

Methocarbamol tablets, USP 500 mg tablets are round standard convex, scored, white to off-white tablet, debossed S 225 on one side and plain on the reverse side.
NDC: 72162-1363-1: 100 Tablets in a BOTTLE

NDC: 72162-1363-5: 500 Tablets in a BOTTLE

Store at controlled room temperature, between 20°C and 25°C (68°F and 77°F).
[see USP Controlled Room Temperature].
Dispense in tight container.

Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504

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SPL UNCLASSIFIED SECTION

Distributed by:
Solco Healthcare U.S., LLC
Somerset, NJ 08873, USA

Manufactured by:
Prinston Laboratories

3241 Woodpark Blvd, Charlotte, NC 28206

Revised: 06/2022
9040321-05

Rx only

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