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
- Proficient Rx LP
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- c796d4a1-fad4-4a0c-a459-8ae3b5b52fb6
- SPL ID
- a4ec7535-0ff1-4a5f-a175-046a5f9cadfb
- Version
- 5
- Effective date
- 2024-01-01
- Source export date
- 2026-10-12
- Source partition
- 1
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:26:50
| 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 | 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 | Proficient Rx LP | openfda.manufacturer_name | |
| ndc | package | 71205-326-20 | openfda.package_ndc |
| ndc | package | 71205-326-90 | openfda.package_ndc |
| ndc | package | 71205-326-30 | openfda.package_ndc |
| ndc | package | 71205-326-60 | openfda.package_ndc |
| ndc | product | 71205-326 | openfda.product_ndc |
| ndc11 | package | 71205032660 | derived:openfda.package_ndc |
| ndc11 | package | 71205032690 | derived:openfda.package_ndc |
| ndc11 | package | 71205032620 | derived:openfda.package_ndc |
| ndc11 | package | 71205032630 | derived:openfda.package_ndc |
| rxcui | 351254 | openfda.rxcui | |
| spl id | a4ec7535-0ff1-4a5f-a175-046a5f9cadfb | id | |
| spl set id | c796d4a1-fad4-4a0c-a459-8ae3b5b52fb6 | 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.