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
- Doc Rx
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 87518046-c959-d5f3-e053-2a95a90a5f7e
- SPL ID
- cd0929e3-c3b2-c89a-e053-2a95a90a7b2a
- Version
- 9
- Effective date
- 2021-09-28
- Source export date
- 2026-09-28
- Source partition
- 8
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:52:50
| 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 | Doc Rx | openfda.manufacturer_name | |
| ndc | package | 69306-100-06 | openfda.package_ndc |
| ndc | package | 69306-100-03 | openfda.package_ndc |
| ndc | package | 69306-100-01 | openfda.package_ndc |
| ndc | package | 69306-100-15 | openfda.package_ndc |
| ndc | package | 69306-100-02 | openfda.package_ndc |
| ndc | package | 69306-100-09 | openfda.package_ndc |
| ndc | product | 69306-100 | openfda.product_ndc |
| ndc11 | package | 69306010015 | derived:openfda.package_ndc |
| ndc11 | package | 69306010003 | derived:openfda.package_ndc |
| ndc11 | package | 69306010001 | derived:openfda.package_ndc |
| ndc11 | package | 69306010006 | derived:openfda.package_ndc |
| ndc11 | package | 69306010002 | derived:openfda.package_ndc |
| ndc11 | package | 69306010009 | derived:openfda.package_ndc |
| rxcui | 351254 | openfda.rxcui | |
| spl id | cd0929e3-c3b2-c89a-e053-2a95a90a7b2a | id | |
| spl set id | 87518046-c959-d5f3-e053-2a95a90a5f7e | 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.