FDA label db596a36-5f82-4d41-a563-e583eb355e56

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
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SPL ID
db596a36-5f82-4d41-a563-e583eb355e56
Version
1
Effective date
2012-09-28
Source export date
2026-08-01
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
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Source manifest SHA-256
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Import run
20260801T225920Z
Imported at
2026-08-01 23:25:18

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS: 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 ). 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.

Adverse reactions cross-check#

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adverse reactions

ADVERSE REACTIONS Adverse reactions reported coincident with the administration of methocarbamol include: Body as a Whole : Anaphylactic reaction, angioneurotic edema, fever, headache Car d iovascular System : Bradycardia, flushing, hypotension, syncope, thrombophlebitis Digestive System : Dyspepsia, jaundice (including cholestatic jaundice), nausea and vomiting Hemic and Lymphatic S ystem : 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 To report SUSPECTED ADVERSE REACTIONS, contact West-ward Pharmaceutical Corp. at 1-877-233-2001, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.