FDA Label for Methocarbamol
View Indications, Usage & Precautions
Methocarbamol Product Label
The following document was submitted to the FDA by the labeler of this product Advanced Rx Pharmacy Of Tennessee, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Dosage And 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.
Indications And 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.
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 100 NDC 76385-123-01
Bottles of 500 NDC 76385-123-50
Methocarbamol Tablets USP, 750 mg are orange colored, capsule shaped, film coated tablets, engraved with 'B135' on one side and plain on the other side. They are supplied as follows:
Bottles of 100 NDC 76385-124-01
Bottles of 500 NDC 76385-124-50
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
Last revised on 12/2017
5001397 111217
* Please review the disclaimer below.
