METHOCARBAMOL tablet, film coated METHOCARBAMOL tablet, coated METHOCARBAMOL tablet

METHOCARBAMOL by

Drug Labeling and Warnings

METHOCARBAMOL by is a Prescription medication manufactured, distributed, or labeled by DirectRX. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Description

Clinical Pharmacology

Pharmacokinetics

Elderly

Special Populations

The clearance of methocarbamol in 8 renally-impaired patients on maintenance hemodialysis was reduced about 40% compared to 17 normal subjects, although the mean (± SD) elimination half-life in these two groups was similar: 1.2 (± 0.6) versus 1.1 (± 0.3) hours, respectively.

Indications and Usage

Contraindications

Warnings

Precautions

Adverse Reactions

Overdosage

Dosage and Administration

How supplied

SPL Unclassified

Package Label

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

METHOCARBAMOL 
methocarbamol tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 61919-627(NDC: 76439-135)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHOCARBAMOL (UNII: 125OD7737X) (METHOCARBAMOL - UNII:125OD7737X)	METHOCARBAMOL	750 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TRIACETIN (UNII: XHX3C3X673)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color	yellow	Score	no score
Shape	CAPSULE	Size	19mm
Flavor		Imprint Code	AP211
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61919-627-90	90 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA200958	01/01/2015

METHOCARBAMOL 
methocarbamol tablet, coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 61919-610(NDC:70010-754)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHOCARBAMOL (UNII: 125OD7737X) (METHOCARBAMOL - UNII:125OD7737X)	METHOCARBAMOL	500 mg

Inactive Ingredients
Ingredient Name	Strength
POVIDONE (UNII: FZ989GH94E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color	orange	Score	2 pieces
Shape	ROUND	Size	13mm
Flavor		Imprint Code	G;500
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61919-610-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	04/18/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA209312	04/18/2019

METHOCARBAMOL 
methocarbamol tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 61919-903(NDC:31722-534)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHOCARBAMOL (UNII: 125OD7737X) (METHOCARBAMOL - UNII:125OD7737X)	METHOCARBAMOL	750 mg

Inactive Ingredients
Ingredient Name	Strength
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
POVIDONE K90 (UNII: RDH86HJV5Z)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white (White to Offwhite)	Score	no score
Shape	OVAL (Capsule shaped)	Size	19mm
Flavor		Imprint Code	115;H
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61919-903-90	90 in 1 BOTTLE; Type 0: Not a Combination Product	04/23/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090200	04/23/2019

Labeler - DirectRX (079254320)

Establishment
Name	Address	ID/FEI	Business Operations
DirectRX		079254320	repack(61919-627, 61919-903) , relabel(61919-610)