FDA label 47cd9014-afad-c751-e063-6294a90ab5a9

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
3632036c-283e-7194-e054-00144ff8d46c
SPL ID
47cd9014-afad-c751-e063-6294a90ab5a9
Version
2
Effective date
2026-01-07
Source export date
2026-09-28
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:27:25

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Section Metaxalone tablets may enhance the effects of alcohol and other CNS depressants. Please review the manufacturer's complete drug information available from the FDA at www.fda.gov Permanent Link: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bb91223e-ffa5-4a3a-b191-fe121250c20c&audience=consumer

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

Adverse Reactions Section The most frequent reactions to metaxalone include: CNS drowsiness, dizziness, headache and nervousness or “irritability”; Digestive nausea, vomiting, gastrointestinal upset. Other adverse reactions are: Immune System hypersensitivity reaction, rash with or without pruritus; Hematologic leukopenia, hemolytic anemia; Hepatobiliary jaundice. Though rare, anaphylactoid reactions have been reported with metaxalone. Please review the manufacturer's complete drug information available from the FDA at www.fda.gov Permanent Link: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bb91223e-ffa5-4a3a-b191-fe121250c20c&audience=consumer

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.