warnings
WARNINGS Metaxalone 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
- Quality Care Products, LLC
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- f05bb280-6736-4215-be5b-0e5f7991cd87
- SPL ID
- f1dd5bd6-120d-44fd-8dc8-61f0e8569020
- Version
- 8
- Effective date
- 2024-12-17
- Source export date
- 2026-10-12
- Source partition
- 7
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 02:03:50
| 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 | Quality Care Products, LLC | openfda.manufacturer_name | |
| ndc | package | 55700-494-30 | openfda.package_ndc |
| ndc | package | 55700-494-90 | openfda.package_ndc |
| ndc | package | 55700-494-21 | openfda.package_ndc |
| ndc | package | 55700-494-60 | openfda.package_ndc |
| ndc | product | 55700-494 | openfda.product_ndc |
| ndc11 | package | 55700049430 | derived:openfda.package_ndc |
| ndc11 | package | 55700049460 | derived:openfda.package_ndc |
| ndc11 | package | 55700049421 | derived:openfda.package_ndc |
| ndc11 | package | 55700049490 | derived:openfda.package_ndc |
| rxcui | 351254 | openfda.rxcui | |
| spl id | f1dd5bd6-120d-44fd-8dc8-61f0e8569020 | id | |
| spl set id | f05bb280-6736-4215-be5b-0e5f7991cd87 | 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.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.