Inactive Ingredients:   ROBAXIN--Corn Starch, FD&C Yellow 6 Aluminum Lake, Hydroxypropyl Cellulose, Hydroxypropyl Methylcellulose, Magnesium Stearate, Polysorbate 20, Povidone, Propylene Glycol, Saccharin Sodium, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Stearic Acid, Titanium Dioxide.

ROBAXIN-750--Corn Starch, D&C Yellow 10 Aluminum Lake, FD&C Yellow 6 Aluminum Lake, Hydroxypropyl Cellulose, Hydroxypropyl Methylcellulose, Magnesium Stearate, Polysorbate 20, Povidone, Propylene Glycol, Saccharin Sodium, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Stearic Acid, Titanium Dioxide.

Methocarbamol has the following structural formula:

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1,2-Propanediol, 3-(2-methoxyphenoxy)-,

1-carbamate, (±)-.

ACTIONS

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

INDICATIONS

Robaxin (methocarbamol) is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.

CONTRAINDICATIONS

Robaxin is contraindicated in patients hypersensitive to any of the ingredients.

Since methocarbamol may possess a general central nervous system depressant effect, patients receiving Robaxin/Robaxin-750 (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. 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.

PRECAUTIONS

Safety and effectiveness in children below the age of 12 years have not been established.

It is not known whether this drug is secreted in human milk. As a general rule, nursing should not be undertaken while a patient is on a drug since many drugs are excreted in human milk.

Methocarbamol may cause a color interference in certain screening tests for 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).

ADVERSE REACTIONS

Lightheadedness, dizziness, drowsiness, nausea, allergic manifestations such as urticaria, pruritus, rash, conjunctivitis with nasal congestion, blurred vision, headache, fever.

DOSAGE AND ADMINISTRATION

Robaxin (methocarbamol), 500 mg--Adults: initial dosage, 3 tablets q.i.d.; maintenance dosage, 2 tablets q.i.d.

Robaxin-750 ( 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.

HOW SUPPLIED

Robaxin--light orange, round, film-coated tablets monogrammed Robaxin and AHR in bottles of 100 (NDC 0031-7429-63), and 500 (NDC 0031-7429-70).

Robaxin-750--orange, capsule-shaped, film-coated tablets monogrammed Robaxin-750 and AHR in bottles of 100 (NDC 0031-7449-63), 500 (NDC 0031-7449-70), and Dis-Co® unit dose packs of 100 (NDC 0031-7449-64).

Store at Controlled Room Temperature, between 20°C and 25°C (68°F and 77°F).

Dispense in tight container.

Also available in the injectable form, 1 g methocarbamol in each 10 ml vial (NDC 0031-7409).

Manufactured by:

Pharmaceutical Division

A.H. Robins Company

Richmond, VA 23220

CI 4696-1     Issued December 17, 1996

PRODUCT PHOTO(S):

NOTE: These photos can be used only for identification by shape, color, and imprint. They do not depict actual or relative size.

The product samples shown here have been supplied by the manufacturer and reproduced in full color by PDR as a quick-reference identification aid. While every effort has been made to assure accurate reproduction, please remember that any visual identification should be considered preliminary. In cases of poisoning or suspected overdosage, the drug' identity should be verified by chemical analysis.

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