METHOCARBAMOL tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

METHOCARBAMOL (UNII: 125OD7737X) (METHOCARBAMOL - UNII:125OD7737X)

Available from:

Bayshore Pharmaceuticals LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Methocarbamol Tablets USP, 500 mg and 750 mg are contraindicated in patients hypersensitive to methocarbamol or to any of the tablet components.

Product summary:

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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METHOCARBAMOL- METHOCARBAMOL TABLET, FILM COATED
BAYSHORE PHARMACEUTICALS LLC
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METHOCARBAMOL TABLETS USP, 500 MG AND 750 MG
(Methocarbamol USP)
Rx Only
DESCRIPTION
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
H
NO . 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, 500 mg is available as a light orange
colored, round, film-
coated tablets, engraved with 'B134' on one side and scored on the
other side,
containing 500 mg of methocarbamol, USP for oral administration. The
inactive
ingredients present are corn starch, low substituted hydroxypropyl
cellulose,
hydroxyprolyl cellulose, sodium starch glycolate, povidone, sodium
lauryl sulfate,
colloidal silicon dioxide, stearic acid, magnesium stearate, and
purified water.
Methocarbamol Tablets USP, 500 mg contains Opadry 13H530000 (Orange)
(hypromellose, titanium dioxide, propylene glycol, FD&C yellow
#6/Sunset Yellow FCF
Aluminum Lake, polysorbate 20) as coating material.
Methocarbamol Tablets USP, 750 mg is available as an orange colored,
capsule shaped,
film coated tablets, engraved with 'B135' on one side and plain on the
other side,
containing 750 mg of methocarbamol, USP for oral administration. It
contains Opadry
13H530001 (Orange) as coating material. The inactive ingredients
present are corn
starch, low substituted hydroxypropyl cellulose, hydroxyprolyl
cellulose, sodium starch
glycolate, povidone, sodium lauryl sulfate, colloidal silicon dioxide,
stearic acid,
magnesium stearate, and purified water. Methocarbamol Tablets USP, 750
mg contain
Opadry 13H530001 (Orange) (hypromellose, titanium