Methocarbamol Tablets 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.
500 mg – Adults: Initial dosage, 3 tablets q.i.d.; maintenance dosage, 2 tablets q.i.d. 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.
METHOCARBAMOL TABLETS, USP
Rx Only
Methocarbamol Tablets, USP, a carbamate derivative of guaifenesin, are a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The structural formula is:
The chemical name for Methocarbamol is 3-(2-Methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24.
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.
Each tablet, for oral administration, contains 500 mg or 750 mg of methocarbamol, USP. In addition each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Lactose Monohydrate, Magnesium Stearate, Methylcellulose, Microcrystalline Cellulose, Pregelatinized Starch and Sodium Starch Glycolate.
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.
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.
The mean (± SD) elimination half-life of methocarbamol in elderly healthy volunteers (mean (± SD) age, 69 (± 4) years) was slightly prolonged compared to a younger (mean (± SD) age, 53.3 (± 8.8) years), healthy population (1.5 (±0.4) hours versus 1.1 (±0.27) hours, respectively). The fraction of bound methocarbamol was slightly decreased in the elderly versus younger volunteers (41 to 43% versus 46 to 50%, respectively).
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.
In 8 patients with cirrhosis secondary to alcohol abuse, the mean total clearance of methocarbamol was reduced approximately 70% compared to that obtained in 8 age- and weight-matched normal subjects. The mean (±SD) elimination half-life in the cirrhotic patients and the normal subjects was 3.38 (±1.62) hours and 1.11 (±0.27) hours, respectively. The percent of methocarbamol bound to plasma proteins was decreased to approximately 40 to 45% compared to 46 to 50% in the normal subjects.
Methocarbamol Tablets 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 are contraindicated in patients hypersensitive to methocarbamol or to any of the tablet components.
Since methocarbamol may possess a general CNS depressant effect, patients receiving Methocarbamol Tablets should
be cautioned about combined effects with alcohol and other CNS depressants.
Safe use of Methocarbamol Tablets 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 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).
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.
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.
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.
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.
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.
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 should be given to a pregnant woman only if clearly needed.
Safe use of Methocarbamol Tablets has not been established with regard to possible adverse effects upon fetal development. There have been reports of fetal and congential abnormalities following in utero exposure to methocarbamol. Therefore, Methocarbamol Tablets 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).
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 are administered to a nursing woman.
Safety and effectiveness of Methocarbamol Tablets in pediatric patients below the age of 16 have not been established.
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
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.
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.
500 mg – Adults: Initial dosage, 3 tablets q.i.d.; maintenance dosage, 2 tablets q.i.d.
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.
Methocarbamol Tablets 500 mg: White, Round, Scored, Compressed Tablet; Debossed “West-ward 290”
Methocarbamol Tablets 750 mg: White, Capsule Shaped, Scored Tablet; Debossed “West-ward 292”
They are supplied by Keltman Pharmaceuticals Inc. as follows:
| NDC | Strength | Quantity/Form | Color | Source Prod. Code |
| 68387-342-60 | 500 mg | 60 Tablets in a Plastic Bottle | WHITE | 0143-1290 |
| 68387-340-30 | 750 mg | 30 Tablets in a Plastic Bottle | WHITE | 0143-1292 |
| 68387-340-45 | 750 mg | 45 Tablets in a Plastic Bottle | WHITE | 0143-1292 |
| 68387-340-60 | 750 mg | 60 Tablets in a Plastic Bottle | WHITE | 0143-1292 |
| 68387-340-90 | 750 mg | 90 Tablets in a Plastic Bottle | WHITE | 0143-1292 |
| 68387-340-24 | 750 mg | 240 Tablets in a Plastic Bottle | WHITE | 0143-1292 |
Store at 20-25oC (68-77oF) [See USP Controlled Room Temperature]. Protect from light and moisture.
Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Manufactured by:
West-ward Pharmaceutical Corp.
Eatontown, NJ 07724
This Product was Repackaged By Sandhills Packaging For:
Keltman Pharmaceuticals Inc.
1 Lakeland Square, Suite A
Flowood, MS 39232
United States
| Class | Version | Type | Effective |
|---|---|---|---|
| METHOCARBAMOL Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 492965be-47bc-38cf-57c4-5c5e0343abe5 | Product name | 6 | 20211028 |
| 02a01e9c-3f4e-c0ee-6542-be865127aea3 | Product name | 8 | 20190205 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68387-340-24 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-bb38-621f-e053-dbdaa90a74ad | Methocarbamol Tablets |
| 68387-340-30 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-bb38-621f-e053-dbdaa90a74ad | Methocarbamol Tablets |
| 68387-340-45 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-bb38-621f-e053-dbdaa90a74ad | Methocarbamol Tablets |
| 68387-340-60 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-bb38-621f-e053-dbdaa90a74ad | Methocarbamol Tablets |
| 68387-340-90 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-bb38-621f-e053-dbdaa90a74ad | Methocarbamol Tablets |
| 68387-342-60 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-bb38-621f-e053-dbdaa90a74ad | Methocarbamol Tablets |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68387-340-24 | Methocarbamol | 240 in 1 BOTTLE, PLASTIC | TABLET | 240 | 1 | |
| 68387-340-30 | Methocarbamol | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | 1 | |
| 68387-340-45 | Methocarbamol | 45 in 1 BOTTLE, PLASTIC | TABLET | 45 | 1 | |
| 68387-340-60 | Methocarbamol | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | 1 | |
| 68387-340-90 | Methocarbamol | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | 1 | |
| 68387-342-60 | Methocarbamol | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68387-340 | METHOCARBAMOL TABLET [KELTMAN PHARMACEUTICALS INC.] | 1 | Legacy NDC, 5 package rows | 20100810_2bdfecbb-d305-4bed-94bf-5c392b07e210.zip |
| 68387-342 | METHOCARBAMOL TABLET [KELTMAN PHARMACEUTICALS INC.] | 1 | Legacy NDC, 1 package rows | 20100810_2bdfecbb-d305-4bed-94bf-5c392b07e210.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68387-342-60 | EA - Each | 68387-342 | 253d3fb6-b35c-415d-9372-7ed57441a95a | 1 | 2012-07-24 |
| 0143-1290-01 | EA - Each | 0143-1290 | 196fbca7-396e-4861-bc66-612d81b70725 | 1 | 2012-07-24 |
| 0143-1290-05 | EA - Each | 0143-1290 | c97fa6d2-5df6-42f3-8e0c-cceeb3996518 | 1 | 2012-07-24 |
| 68387-340-24 | EA - Each | 68387-340 | aae6e59a-cdf0-4a85-8b1e-91bb1554b571 | 1 | 2012-07-24 |
| 68387-340-30 | EA - Each | 68387-340 | 233d9162-6131-4314-9d6f-8faa0c52cb71 | 1 | 2012-07-24 |
| 68387-340-45 | EA - Each | 68387-340 | 48fa1628-91d6-4b0a-8366-2c950e101f45 | 1 | 2012-07-24 |
| 68387-340-60 | EA - Each | 68387-340 | 0ae08f43-9eae-4e2e-9ece-0dfdc8012495 | 1 | 2012-07-24 |
| 68387-340-90 | EA - Each | 68387-340 | 771b935c-d865-4eb9-a65b-24ad378fd602 | 1 | 2012-07-24 |
| 0143-1292-01 | EA - Each | 0143-1292 | 1bba3b86-7404-4f74-811a-db6021b6b526 | 1 | 2012-07-24 |
| 0143-1292-05 | EA - Each | 0143-1292 | 61582194-362f-419c-adb1-1ee34424a8f5 | 1 | 2012-07-24 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| METHOCARBAMOL | ACTIVE INGREDIENT | 125OD7737X | 1 | |
| METHOCARBAMOL | ACTIVE MOIETY | 125OD7737X | 1 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| METHYLCELLULOSE (100 CPS) | INACTIVE INGREDIENT | 4GFU244C4J | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68387-342 | 68387-342-60 |
| 0143-1290 | |
| 68387-340 | 68387-340-30, 68387-340-45, 68387-340-60, 68387-340-90, 68387-340-24 |
| 0143-1292 |
Every source-derived ingredient row is available through these pages.
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, CHEWABLE / ORAL | 1412 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | GRANULE, FOR SUSPENSION / ORAL | 14 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE / ORAL | 127 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | CAPSULE / ORAL | 3990 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | GRANULE, FOR SOLUTION / ORAL | 1691.8 mg/120ml | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | PELLET / ORAL | 24 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / DENTAL | 19 %w/w | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION / SUBCUTANEOUS | 98 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SYSTEM / INTRAVITREAL | 0.02 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / TOPICAL | 6 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE, DELAYED RELEASE / ORAL | 216 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 53 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | RING / VAGINAL | 2 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 9.5 %w/v | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / BUCCAL | 17.5 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET / ORAL | 4384 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET / BUCCAL | 43 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, LIQUID FILLED / ORAL | 106 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / ORAL | 300 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SUSPENSION, EXTENDED RELEASE / ORAL | 71 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | POWDER, FOR SUSPENSION / ORAL | 34 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / ORAL | 25 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, FILM COATED / ORAL | 968 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SYSTEM / TRANSDERMAL | 35 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | IMPLANT / INTRAVITREAL | NA | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 69 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | NA | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | GRANULE / ORAL | 8946 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 19 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION / INTRAMUSCULAR | 150 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED / ORAL | 96 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / ORAL | 750 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SUSPENSION / ORAL | 200 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, DELAYED RELEASE PARTICLES / ORAL | 170 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET, FOR SUSPENSION / ORAL | 2794 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 21 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / VAGINAL | 8 %w/w | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | INSERT / VAGINAL | 147 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, DELAYED RELEASE / ORAL | 1190 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUPPOSITORY / RECTAL | 14 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | TABLET / SUBLINGUAL | 505 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CREAM / VAGINAL | 51 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | INSERT / VAGINAL | 8 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY | 47.5 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | PELLET / ORAL | 640 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED / ORAL | 3 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / ORAL | 1116 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | GRANULE, FOR SUSPENSION / ORAL | NA | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | PELLET / ORAL | 34 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SUSPENSION / ORAL | 2553 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SOLUTION / ORAL | 280 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, EXTENDED RELEASE / ORAL | 117 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CONCENTRATE / ORAL | NA | ||
| LACTOSE MONOHYDRATE | LACTOSE MONOHYDRATE | EWQ57Q8I5X | CAPSULE, DELAYED RELEASE / ORAL | 2087 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 9 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FOR SUSPENSION / ORAL | 131 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / RESPIRATORY (INHALATION) | NA |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A085123-001 | METHOCARBAMOL | METHOCARBAMOL | 750MG | TABLET / ORAL | Approved before 1982 | ||
| A085123-002 | METHOCARBAMOL | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 |
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A085123-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A085123-002 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A085123-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A085123-002 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A085123-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A085123-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A085123-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A085123-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A085123-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A085123-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A085123-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A085123-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A085123-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A085123-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A085123-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A085123-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A085123-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A085123-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A085123-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A085123-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A085123-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A085123-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | Approved before 1982 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A085123-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | Approved before 1982 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A085123-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | Approved before 1982 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A085123-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | Approved before 1982 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A085123-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | Approved before 1982 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A085123-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | Approved before 1982 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A085123-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | Approved before 1982 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A085123-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | Approved before 1982 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A085123-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | Approved before 1982 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A085123-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | AA | Approved before 1982 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A085123-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | Approved before 1982 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A085123-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | Approved before 1982 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A085123-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | Approved before 1982 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A085123-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | Approved before 1982 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A085123-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | Approved before 1982 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A085123-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | Approved before 1982 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A085123-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | Approved before 1982 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A085123-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | Approved before 1982 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A085123-001 | METHOCARBAMOL | 750MG | TABLET / ORAL | Approved before 1982 | 3bdfa0b2c4d7… |
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A085123-001 | AA | 1 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | A085123-001 | AA | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A085123-001 | AA | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A085123-001 | AA | 1 | ea99ee380514… |
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A085159-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A085159-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A085159-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A085159-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A085159-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A085159-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A085159-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A085159-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A085159-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A085159-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A085159-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A085159-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A085159-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A085159-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A085159-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A085159-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A085159-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A085159-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | Approved before 1982 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A085159-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A085159-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A085159-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A085159-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A085159-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A085159-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A085159-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | Approved before 1982 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A085159-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | Approved before 1982 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A085159-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | AA | Approved before 1982 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A085159-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A085159-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A085159-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A085159-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A085159-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A085159-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A085159-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A085159-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A085159-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A085159-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A085159-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A085159-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A085159-001 | METHOCARBAMOL | 500MG | TABLET / ORAL | Approved before 1982 | cb3db0bc1861… |
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A085159-001 | AA | 1 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | A085159-001 | AA | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A085159-001 | AA | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A085159-001 | AA | 1 | ea99ee380514… |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 164d7dfa-e10c-4ca9-863a-1837e73b6522 | 2bdfecbb-d305-4bed-94bf-5c392b07e210 | 2010-08-09 | Warnings, Adverse reactions | 164d7dfa-e10c-4ca9-863a-1837e73b6522 2bdfecbb-d305-4bed-94bf-5c392b07e210 |
Adverse event summaries are temporarily unavailable. Other product information remains available.