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
- 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
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | 47cd9014-afad-c751-e063-6294a90ab5a9 | id | |
| spl set id | 3632036c-283e-7194-e054-00144ff8d46c | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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.