Label: METHOCARBAMOL tablet, coated
METHOCARBAMOL tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 13, 2024

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  • DESCRIPTION

    Methocarbamol tablets, USP, a carbamate derivative of guaifenesin, are a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties.

    The chemical name of methocarbamol is 3-(2-meth-oxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24. The structural formula is shown below.

    [Methocarbamol Chemical Structure]

    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 are available as 500 mg and 750 mg tablets for oral administration. Methocarbamol tablets, USP 500 mg and 750 mg contain the following inactive ingredients: povidone, sodium starch glycolate and magnesium stearate.

  • CLINICAL PHARMACOLOGY

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

  • Pharmacokinetics

    In healthy volunteers, the plasma clearance of methocarbamol ranges between 0.20 and 0.80 L/h/kg, the mean plasma elimination half-life ranges between 1 and 2 hours, and the plasma protein binding ranges between 46% and 50%.

    Methocarbamol is metabolized via dealkylation and hydroxylation. Conjugation of methocarbamol also is likely. Essentially all methocarbamol metabolites are eliminated in the urine. Small amounts of unchanged methocarbamol also are excreted in the urine.

  • 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.

  • CONTRAINDICATIONS

    Methocarbamol tablets, USP are contraindicated in patients hypersensitive to methocarbamol or to any of the tablet components.

  • WARNINGS

    Since methocarbamol may possess a general CNS depressant effect, patients receiving Methocarbamol tablets, USP should be cautioned about combined effects with alcohol and other CNS depressants.

    Safe use of Methocarbamol tablets, USP has not been established with regard to possible adverse effects upon fetal development. There have been reports of fetal and congenital abnormalities following in utero exposure to methocarbamol. Therefore, Methocarbamol tablets, USP 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 (see Precautions, Pregnancy).

    Use In Activities Requiring Mental Alertness

    Methocarbamol may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle. Patients should be cautioned about operating machinery, including automobiles, until they are reasonably certain that methocarbamol therapy does not adversely affect their ability to engage in such activities

  • PRECAUTIONS

    Information for patients

    Patients should be cautioned that methocarbamol may cause drowsiness or dizziness, which may impair their ability to operate motor vehicles or machinery.

    Because methocarbamol may possess a general CNS-depressant effect, patients should be cautioned about combined effects with alcohol and other CNS depressants.

    Drug interactions

    See Warnings and Precautions for interaction with CNS drugs and alcohol.

    Methocarbamol may inhibit the effect of pyridostigmine bromide. Therefore, methocarbamol should be used with caution in patients with myasthenia gravis receiving anticholinesterase agents.

    Drug/laboratory test interactions

    Methocarbamol may cause a color interference in certain screening tests for 5-hydroxyindoleacetic acid (5-HIAA) using nitrosonaphthol reagent and in screening tests for urinary vanillylmandelic acid (VMA) using the Gitlow method.

    Carcinogenesis, mutagenesis, impairment of fertility

    Long-term studies to evaluate the carcinogenic potential of methocarbamol have not been performed. No studies have been conducted to assess the effect of methocarbamol on mutagenesis or its potential to impair fertility.

    Pregnancy

    Teratogenic effects

    Pregnancy Category C

    Animal reproduction studies have not been conducted with methocarbamol. It is also not known whether methocarbamol can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Methocarbamol tablets, USP should be given to a pregnant woman only if clearly needed.

    Safe use of Methocarbamol tablets, USP has not been established with regard to possible adverse effects upon fetal development. There have been reports of fetal and congenital abnormalities following in utero exposure to methocarbamol. Therefore, Methocarbamol tablets, USP 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 (see Warnings).

    Nursing mothers

    Methocarbamol and/or its metabolites are excreted in the milk of dogs; however, it is not known whether methocarbamol or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Methocarbamol tablets, USP are administered to a nursing woman.

    Pediatric use

    Safety and effectiveness of Methocarbamol tablets, USP in pediatric patients below the age of 16 have not been established.

  • ADVERSE REACTIONS

    Adverse reactions reported coincident with the administration of methocarbamol include:

    Body as a whole:

    Anaphylactic reaction, angioneurotic edema, fever, headache

    Cardiovascular system:

    Bradycardia, flushing, hypotension, syncope, thrombophlebitis

    Digestive system:

    Dyspepsia, jaundice (including cholestatic jaundice), nausea and vomiting

    Hemic and lymphatic system:

    Leukopenia

    Immune system:

    Hypersensitivity reactions

    Nervous system:

    Amnesia, confusion, diplopia, dizziness or lightheadedness, drowsiness, insomnia, mild muscular incoordination, nystagmus, sedation, seizures (including grand mal), vertigo

    Skin and special senses:

    Blurred vision, conjunctivitis, nasal congestion, metallic taste, pruritus, rash, urticaria

  • OVERDOSAGE

    Limited information is available on the acute toxicity of methocarbamol. Overdose of methocarbamol is frequently in conjunction with alcohol or other CNS depressants and includes the following symptoms: nausea, drowsiness, blurred vision, hypotension, seizures, and coma.

    In post-marketing experience, deaths have been reported with an overdose of methocarbamol alone or in the presence of other CNS depressants, alcohol or psychotropic drugs.

    Treatment

    Management of overdose includes symptomatic and supportive treatment. Supportive measures include maintenance of an adequate airway, monitoring urinary output and vital signs, and administration of intravenous fluids if necessary. The usefulness of hemodialysis in managing overdose is unknown.

  • 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.

  • STORAGE

    Store at controlled room temperature, between 20°C and 25°C (68°F and 77°F).
    [see USP Controlled Room Temperature].
    Dispense in tight container.

  • HOW SUPPLIED

    Methocarbamol tablets, USP 500 mg are white to off white, capsule shaped, tablets debossed with ‘H’ on scored side and ‘114’ on unscored side .

    Methocarbamol tablets, USP 750 mg are light orange colored, capletshaped film coated tablets debossed with "G" on one side and"750" on other side.


    Store between 20ºC and 25ºC (68ºF and 77º F)

    [see USP Controlled Room Temperature].

    Dispense in tight container.


    Manufactured for:

    Granules USA, Inc.

    Parsippany, NJ 07054

    Toll-free: 1-877-770-3183


    Manufactured by:

    Granules India Limited

    Hyderabad-500 081

    Made in India


    Issued: January 2017

  • PACKAGE LABEL 750MG

    METHOCARBAMOL 750mg 120TABS

  • PRINCIPAL DISPLAY PANEL

    368-30

  • PRINCIPAL DISPLAY PANEL

    616-30

  • PRINCIPAL DISPLAY PANEL

    61919-616-60

  • PRINCIPAL DISPLAY PANEL

    368-40

  • PRINCIPAL DISPLAY PANEL

    368-60

  • PRINCIPAL DISPLAY PANEL

    61919-368-90

  • PRINCIPAL DISPLAY PANEL

    368-07

  • PRINCIPAL DISPLAY PANEL

    61919-616-20

  • INGREDIENTS AND APPEARANCE
    METHOCARBAMOL 
    methocarbamol tablet, coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61919-616(NDC:70010-770)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHOCARBAMOL (UNII: 125OD7737X) (METHOCARBAMOL - UNII:125OD7737X) METHOCARBAMOL750 mg
    Inactive Ingredients
    Ingredient NameStrength
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColororangeScoreno score
    ShapeCAPSULESize19mm
    FlavorImprint Code G;750
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61919-616-3030 in 1 BOTTLE; Type 0: Not a Combination Product04/18/2019
    2NDC:61919-616-6060 in 1 BOTTLE; Type 0: Not a Combination Product04/18/2019
    3NDC:61919-616-2020 in 1 BOTTLE; Type 0: Not a Combination Product04/18/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20931204/18/2019
    METHOCARBAMOL 
    methocarbamol tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61919-148(NDC:43547-226)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHOCARBAMOL (UNII: 125OD7737X) (METHOCARBAMOL - UNII:125OD7737X) METHOCARBAMOL750 mg
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Colorwhite (White to off White) Scoreno score
    ShapeCAPSULE (Capsule Shaped) Size18mm
    FlavorImprint Code S226
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61919-148-72120 in 1 BOTTLE; Type 0: Not a Combination Product03/22/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA08698803/22/2016
    METHOCARBAMOL 
    methocarbamol tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61919-368(NDC:31722-533)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHOCARBAMOL (UNII: 125OD7737X) (METHOCARBAMOL - UNII:125OD7737X) METHOCARBAMOL500 mg
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    Product Characteristics
    Colorwhite (White to Offwhite) Score2 pieces
    ShapeOVAL (Capsule shaped) Size15mm
    FlavorImprint Code 114;H
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61919-368-3030 in 1 BOTTLE; Type 0: Not a Combination Product04/18/2019
    2NDC:61919-368-4040 in 1 BOTTLE; Type 0: Not a Combination Product04/18/2019
    3NDC:61919-368-077 in 1 BOTTLE; Type 0: Not a Combination Product04/18/2019
    4NDC:61919-368-6060 in 1 BOTTLE; Type 0: Not a Combination Product04/18/2019
    5NDC:61919-368-9090 in 1 BOTTLE; Type 0: Not a Combination Product04/18/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09020004/18/2019
    Labeler - DIRECT RX (079254320)
    Establishment
    NameAddressID/FEIBusiness Operations
    DIRECT RX079254320repack(61919-148, 61919-368) , relabel(61919-616)