Methocarbamol Tablets USP 8205601/0418 Rx Only

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 C ₁₁H ₁₅NO ₅. Its molecular weight is 241.24. The structural formula is shown below.

Methocarbamol USP 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: sodium lauryl sulfate, sodium starch glycolate, povidone K 90, polyethylene glycol, magnesium stearate, colloidal silicon dioxide, low substituted hydroxypropyl cellulose and stearic acid.

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.

Methocarbamol tablets 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.

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

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 tablets 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).

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, urticarial

Limited information is available on the acute toxicity of methocarbamol. Overdose of methocarbamol is frequently in conjunction with alcohol or other CNS depressants and includes the following symptoms: nausea, drowsiness, blurred vision, hypotension, seizures, and coma.

In post-marketing experience, deaths have been reported with an overdose of methocarbamol alone or in the presence of other CNS depressants, alcohol or psychotropic drugs.

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.

Methocarbamol tablets USP, 500 mg are white to off white, capsule shaped, tablets debossed with ‘H’ on scored side and ‘114’ on unscored side . They are supplied as follows:
Unit dose packages of 100 (10 x 10) NDC 68084-056-01

Methocarbamol tablets USP, 750 mg are white to off white, capsule shaped, tablets debossed with ‘H’ on one side and ‘115’ on other side . They are supplied as follows:
Unit dose packages of 100 (10 x 10) NDC 68084-057-01

Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature].

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

PACKAGING INFORMATION
American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Camber Pharmaceuticals Inc. as follows:
(500 mg / 100 UD) NDC 68084-056-01 packaged from NDC 31722-533
(750 mg / 100 UD) NDC 68084-057-01 packaged from NDC 31722-534

Distributed by:
American Health Packaging
Columbus, OH 43217

8205601/0418

NDC 68084-056-01

Methocarbamol
Tablets USP

500 mg

100 Tablets (10 x 10)

Each Uncoated Tablet Contains:
Methocarbamol USP ......................................500 mg

Usual Dosage: Two to four tablets four times daily. See
package insert for full prescribing information.

Store at 20° to 25°C (68° to 77°F); excursions permitted
between 15° to 30°C (59° to 86°F) [see USP Controlled Room
Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn
or broken.

Rx Only

The drug product contained in this package is from
NDC # 31722-533, Camber Pharmaceuticals, Inc.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

005601
0205601/0216PS

Methocarbamol
Tablet USP

500 mg

NDC 68084-057-01

Methocarbamol
Tablets USP

750 mg

100 Tablets (10 x 10)

Each Uncoated Tablet Contains:
Methocarbamol USP .......................................750 mg

Usual Dosage: Two tablets three times daily. See
package insert for full prescribing information.

Store at 20° to 25°C (68° to 77°F); excursions
permitted between 15° to 30°C (59° to 86°F)
[see USP Controlled Room Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn
or broken.

Rx Only

The drug product contained in this package is from
NDC # 31722-534, Camber Pharmaceuticals, Inc.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

005701
0205701/0418

Methocarbamol
Tablet USP

750 mg