warnings
Metaxalone tablets may enhance the effects of alcohol and other CNS depressants.
METAXALONE
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
- Brand name
- METAXALONE
- Generic name
- METAXALONE
- Manufacturer
- DIRECT RX
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 49250bbf-fbfe-07cd-e054-00144ff88e88
- SPL ID
- 47e15fc2-987b-4fa9-e063-6294a90adf51
- Version
- 4
- Effective date
- 2026-01-08
- Source export date
- 2026-09-28
- Source partition
- 11
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:17:12
| Harmonized routes |
|---|
| ORAL |
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 |
|---|---|---|---|
| application applno | ANDA | 204770 | derived:openfda.application_number |
| application number | ANDA204770 | openfda.application_number | |
| brand name | METAXALONE | openfda.brand_name | |
| generic name | METAXALONE | openfda.generic_name | |
| manufacturer name | DIRECT RX | openfda.manufacturer_name | |
| ndc | package | 61919-091-30 | openfda.package_ndc |
| ndc | package | 61919-832-90 | openfda.package_ndc |
| ndc | product | 61919-832 | openfda.product_ndc |
| ndc | product | 61919-091 | openfda.product_ndc |
| ndc11 | package | 61919083290 | derived:openfda.package_ndc |
| ndc11 | package | 61919009130 | derived:openfda.package_ndc |
| rxcui | 351254 | openfda.rxcui | |
| spl id | 47e15fc2-987b-4fa9-e063-6294a90adf51 | id | |
| spl set id | 49250bbf-fbfe-07cd-e054-00144ff88e88 | set_id | |
| unii | 1NMA9J598Y | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
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.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.