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| Product NDC Code | 61919-610 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Methocarbamol |
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| Type | Generic | ||||||||||
| Pharm Class | Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||||||||
| Dosage Form | TABLET, COATED | ||||||||||
| RxCUI drug identifier | 197943, 197944 |
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| Application Number | ANDA209312 | ||||||||||
| Labeler Name | DirectRX | ||||||||||
| Packages |
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Overdosage of Methocarbamol
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.Overdosage
Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.Adverse Reactions
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.Clinical Pharmacology
Pharmacokinetics
Information about the clinically significant pharmacokinetics of a drug or active metabolites, for instance pertinent absorption, distribution, metabolism, and excretion parameters.Pharmacokinetics
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.Contraindications
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.Description
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Dosage and Administration
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Indications and Usage
Spl product data elements
Usually a list of ingredients in a drug product.METHOCARBAMOL METHOCARBAMOL CROSCARMELLOSE SODIUM FERRIC OXIDE YELLOW FERRIC OXIDE RED HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED TRIACETIN TITANIUM DIOXIDE METHOCARBAMOL METHOCARBAMOL CELLULOSE, MICROCRYSTALLINE AP211 Methocarbamol Methocarbamol POVIDONE POLYSORBATE 80 SODIUM LAURYL SULFATE TITANIUM DIOXIDE SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN STEARIC ACID FD&C YELLOW NO. 6 FOOD YELLOW 3 FREE ACID HYDROXYPROPYL CELLULOSE (1600000 WAMW) METHOCARBAMOL METHOCARBAMOL HYPROMELLOSE 2910 (6 MPA.S) PROPYLENE GLYCOL G;500 METHOCARBAMOL METHOCARBAMOL METHOCARBAMOL METHOCARBAMOL SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE A POTATO POVIDONE K90 POLYETHYLENE GLYCOL, UNSPECIFIED MAGNESIUM STEARATE SILICON DIOXIDE HYDROXYPROPYL CELLULOSE (1600000 WAMW) STEARIC ACID White to Offwhite 115;H Capsule shaped
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Package Label Label
610-60
903-90
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.SPL Unclassified
Geriatric use
Information about any limitations on any geriatric indications, needs for specific monitoring, hazards associated with use of the drug in the geriatric population.Elderly
Use in specific populations
Information about use of the drug by patients in specific populations, including pregnant women and nursing mothers, pediatric patients, and geriatric patients.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.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.How supplied
Precautions
Information about any special care to be exercised for safe and effective use of the drug.Precautions
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API