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 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 Section
DOSAGE AND ADMINISTRATION
Methocarbamol Tablets, USP 500 mg – Adults:
Initial dosage: 3 tablets 4 times daily
Maintenance dosage: 2 tablets 4 times daily
Methocarbamol Tablets, USP 750 mg – Adults:
Initial dosage: 2 tablets 4 times daily
Maintenance dosage: 1 tablet every 4 hours or 2 tablets 3 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.
How Supplied Section
HOW SUPPLIED
Methocarbamol tablets, USP 500 mg are light orange colored, round shaped film coated tablets debossed with "G" above the score line onone side and "500" on other side.
They are supplied as follows
Bottles of 100 tablets NDC 70010-754-01
Bottles of 500 tablets NDC 70010-754-05
Methocarbamol tablets, USP 750 mg are light orange colored, caplet shaped film coated tablets debossed with "G" on one side and"750" on other side.
Bottles of 100 tablets NDC 70010-770-01
Bottles of 500 tablets NDC 70010-770-05
Store between 20°C and 25°C (68°F and 77° F)
[see USP Controlled Room Temperature].
Dispense in tight container.
Manufactured for:
Granules Pharmaceuticals Inc.,
Chantilly, VA 20151
Manufactured by:
Granules India Limited
Hyderabad-500 081
Made in India
Issued: February 2020
Indications And 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.
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