meloxicam
- Manufacturer
- New Horizon Rx Group, LLC | Unichem Laboratories Limited
- Effective date
- 2013-12-30
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 20:17:33
Key Label Information#
Warnings
WARNING: RISK OF CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
Cardiovascular Risk Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk [ see Warnings and Precautions (5.1) ]. Meloxicam tablets are contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications (4.2) and Warnings and Precautions (5.1) ]. Gastrointestinal Risk NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse reactions including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events [see Warnings and Precautions (5.2) ].
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
Directions And Dosage
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
Tablets: 15 mg: Light yellow, capsule shaped, biconvex, tablet with UL debossed on one side and 15 debossed centrally on the other side.
10 OVERDOSAGE
There is limited experience with meloxicam overdose. Four cases have taken 6 to 11 times the highest recommended dose; all recovered. Cholestyramine is known to accelerate the clearance of meloxicam. Symptoms following acute NSAID overdose include lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Severe poisoning may result in hypertension, acute renal failure, hepatic dysfunction, respiratory depression, coma, convulsions, cardiovascular collapse, and cardiac arrest. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose. Patients should be managed with symptomatic and supportive care following an NSAID overdose. Administration of activated charcoal is recommended for patients who present 1-2 hours after overdose. For substantial overdose or severely symptomatic patients, activated charcoal may be administered repeatedly. Accelerated removal of meloxicam by 4 gm oral doses of cholestyramine given three times a day was demonstrated in a clinical trial. Administration of cholestyramine may be useful following an overdose. Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding. For additional information about overdose treatment, call a poison control center (1-800-222-1222).
Other Label Information
16. HOW SUPPLIED/STORAGE AND HANDLING
Meloxicam Tablets USP are available as light yellow, oblong, biconvex, uncoated tablets containing meloxicam 15 mg. The 15 mg tablet is impressed with letter U and L on one side and tablet code 15 on the other side. Meloxicam Tablets USP 15 mg are available as follows: NDC 58517-260-30 Bottles of 30 STORAGE Store at Controlled Room Temperature 20°-25°C (68°-77°F) [See USP]. Keep Meloxicam Tablets USP in a dry place Dispense tablets in a tight container. Keep this and all medications out of the reach of children.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Label Images#
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| MELOXICAM Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20191108 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bdef11ce-16e2-4690-96a3-597bcf5cc738 | Product name | 1 | 20260130 |
| f2791553-0b76-42f4-8d49-af3eda072bfb | Product name | 1 | 20251117 |
| e3a99641-4540-4894-9108-00cab3c57b7e | Product name | 1 | 20211207 |
| 3e9b4ed6-844c-4725-9d19-cceb5c823572 | Product name | 2 | 20210903 |
| b21a682e-c765-4e26-9bb2-dbb8c7b38ef7 | Product name | 1 | 20200623 |
| a428d1db-64d7-4fc3-8d13-832b1e84b683 | Product name | 1 | 20190201 |
| 96649a58-aac8-401c-be00-450b4335f7e7 | Product name | 1 | 20161116 |
| f0761cb7-8207-3a19-2ca3-ecbb559b04e1 | Product name | 2 | 20161116 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 58517-260-30 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-3d9e-60a7-e053-dbdaa90a05bd | These highlights do not include all the information needed to use meloxicam safely and effectively. See full prescribing information for meloxicam. meloxicam (meloxicam) TABLET for ORAL use. Initial U.S. Approval: 2000 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58517-260-30 | meloxicam | 30 in 1 BOTTLE | TABLET | 30 | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 58517-260-30 | EA - Each | 58517-260 | e47925b1-c1ba-4433-b371-89badba68ce0 | 1 | 2013-11-04 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| MELOXICAM | ACTIVE INGREDIENT | VG2QF83CGL | 2 | |
| MELOXICAM | ACTIVE MOIETY | VG2QF83CGL | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 2 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 2 | |
| POVIDONE K29/32 | INACTIVE INGREDIENT | 390RMW2PEQ | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 2 | |
| TRISODIUM CITRATE DIHYDRATE | INACTIVE INGREDIENT | B22547B95K | 2 |
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58517-260 | 58517-260-30 |
Ingredients#
| Name | UNII | Kind |
|---|---|---|
| MELOXICAM | VG2QF83CGL | ACTIB |
| CROSPOVIDONE | 68401960MK | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| TRISODIUM CITRATE DIHYDRATE | B22547B95K | IACT |
| POVIDONE K29/32 | 390RMW2PEQ | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
Complete SPL Sections#
WARNING: RISK OF CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
Cardiovascular Risk Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk [ see Warnings and Precautions (5.1) ]. Meloxicam tablets are contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications (4.2) and Warnings and Precautions (5.1) ]. Gastrointestinal Risk NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse reactions including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events [see Warnings and Precautions (5.2) ].
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
Tablets: 15 mg: Light yellow, capsule shaped, biconvex, tablet with UL debossed on one side and 15 debossed centrally on the other side.
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
6 ADVERSE REACTIONS
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following serious adverse reactions are discussed elsewhere in the labeling: Cardiovascular thrombotic events [see Boxed Warning and Warnings and Precautions (5.1) ] Gastrointestinal effects – risk of GI ulceration, bleeding, and perforation [see Boxed Warning and Warnings and Precautions (5.2) ] Hepatic effects [see Warnings and Precautions (5.3) ] Hypertension [see Warnings and Precautions (5.4) ] Congestive heart failure and edema [see Warnings and Precautions (5.5) ] Renal effects [see Warnings and Precautions (5.6) ] Anaphylactoid reactions [see Warnings and Precautions (5.7) ] Adverse skin reactions [see Warnings and Precautions (5.8) ]
7 DRUG INTERACTIONS
See also Clinical Pharmacology ( 12.3 ).
8 USE IN SPECIFIC POPULATIONS
10 OVERDOSAGE
There is limited experience with meloxicam overdose. Four cases have taken 6 to 11 times the highest recommended dose; all recovered. Cholestyramine is known to accelerate the clearance of meloxicam. Symptoms following acute NSAID overdose include lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Severe poisoning may result in hypertension, acute renal failure, hepatic dysfunction, respiratory depression, coma, convulsions, cardiovascular collapse, and cardiac arrest. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose. Patients should be managed with symptomatic and supportive care following an NSAID overdose. Administration of activated charcoal is recommended for patients who present 1-2 hours after overdose. For substantial overdose or severely symptomatic patients, activated charcoal may be administered repeatedly. Accelerated removal of meloxicam by 4 gm oral doses of cholestyramine given three times a day was demonstrated in a clinical trial. Administration of cholestyramine may be useful following an overdose. Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding. For additional information about overdose treatment, call a poison control center (1-800-222-1222).
11 DESCRIPTION
Meloxicam, an oxicam derivative, is a member of the enolic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl- N -(5-methyl-2-thiazolyl)-2 H -1,2-benzothiazine-3carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14 H 13 N 3 O 4 S 2 and it has the following structural formula. Meloxicam is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P)app = 0.1 in n -octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing or 15 mg meloxicam. The inactive ingredients in Meloxicam tablets USP include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and sodium citrate dihydrate.
12 CLINICAL PHARMACOLOGY
13 NONCLINICAL TOXICOLOGY
14 CLINICAL STUDIES
16. HOW SUPPLIED/STORAGE AND HANDLING
Meloxicam Tablets USP are available as light yellow, oblong, biconvex, uncoated tablets containing meloxicam 15 mg. The 15 mg tablet is impressed with letter U and L on one side and tablet code 15 on the other side. Meloxicam Tablets USP 15 mg are available as follows: NDC 58517-260-30 Bottles of 30 STORAGE Store at Controlled Room Temperature 20°-25°C (68°-77°F) [See USP]. Keep Meloxicam Tablets USP in a dry place Dispense tablets in a tight container. Keep this and all medications out of the reach of children.
17 PATIENT COUNSELING INFORMATION
See FDA-approved Medication Guide Patients should be informed of the following information before initiating therapy with an NSAID and periodically during the course of ongoing therapy.