warnings
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
- Bryant Ranch Prepack
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- c2dd7071-cba3-410c-ade5-9d7e5af42038
- SPL ID
- b97be1a8-3fbc-4207-b88e-18ed1f3ca33c
- Version
- 11
- Effective date
- 2024-09-16
- Source export date
- 2026-10-12
- Source partition
- 9
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 02:25:35
| 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 | 203695 | derived:openfda.application_number |
| application number | ANDA203695 | openfda.application_number | |
| brand name | Metaxalone | openfda.brand_name | |
| generic name | METAXALONE | openfda.generic_name | |
| manufacturer name | Bryant Ranch Prepack | openfda.manufacturer_name | |
| ndc | package | 71335-0375-4 | openfda.package_ndc |
| ndc | package | 71335-0375-9 | openfda.package_ndc |
| ndc | package | 71335-0375-7 | openfda.package_ndc |
| ndc | package | 71335-0375-2 | openfda.package_ndc |
| ndc | package | 71335-0375-0 | openfda.package_ndc |
| ndc | package | 71335-0375-5 | openfda.package_ndc |
| ndc | package | 71335-0375-6 | openfda.package_ndc |
| ndc | package | 71335-0375-8 | openfda.package_ndc |
| ndc | package | 71335-0375-3 | openfda.package_ndc |
| ndc | package | 71335-0375-1 | openfda.package_ndc |
| ndc | product | 71335-0375 | openfda.product_ndc |
| ndc11 | package | 71335037500 | derived:openfda.package_ndc |
| ndc11 | package | 71335037509 | derived:openfda.package_ndc |
| ndc11 | package | 71335037504 | derived:openfda.package_ndc |
| ndc11 | package | 71335037507 | derived:openfda.package_ndc |
| ndc11 | package | 71335037506 | derived:openfda.package_ndc |
| ndc11 | package | 71335037502 | derived:openfda.package_ndc |
| ndc11 | package | 71335037508 | derived:openfda.package_ndc |
| ndc11 | package | 71335037501 | derived:openfda.package_ndc |
| ndc11 | package | 71335037505 | derived:openfda.package_ndc |
| ndc11 | package | 71335037503 | derived:openfda.package_ndc |
| rxcui | 351254 | openfda.rxcui | |
| spl id | b97be1a8-3fbc-4207-b88e-18ed1f3ca33c | id | |
| spl set id | c2dd7071-cba3-410c-ade5-9d7e5af42038 | 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
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. To report SUSPECTED ADVERSE EVENTS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.