Meloxicam Tablet
Product Images NDC 71610-583

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Meloxicam (NDC 71610-583). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aphena Pharma Solutions - Tennessee, Llc, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

71610 0583 15

Meloxicam USP 7.5 mg oral tablets label for a package containing 15 tablets. The label includes the NDC number 71610-0583-15 and storage instructions to keep the tablets between 20-25 degrees Celsius. It lists Aphena Pharma Solutions - Tennessee, LLC as the repackager and Ascent Pharmaceuticals, Inc. as the manufacturer. The label includes warnings to keep out of reach of children and mentions tight-resistant container dispensing.*

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Adverse Reactions (Adverse Reactions)

A text panel listing adverse reactions by system organ class including body as a whole, cardiovascular, central and peripheral nervous system, gastrointestinal, heart rate and rhythm, hematologic, liver and biliary system, metabolic and nutritional, psychiatric, respiratory, skin and appendages, special senses, and urinary system symptoms and conditions.*

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Aphena Pharma Solutions (TN)

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Structure (Struct)

Chemical structure of Meloxicam, showing its molecular composition including a benzothiazine core, sulfonamide group, and a methylthiazole ring.*

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Table 1a (Table 1a)

A data table presenting adverse event percentages occurring in at least 2% of patients treated with Meloxicam in a 12-week osteoarthritis placebo- and active-controlled trial. It compares placebo, Meloxicam 7.5 mg daily, Meloxicam 15 mg daily, and Diclofenac 100 mg daily across various categories such as gastrointestinal, body as a whole, central and peripheral nervous system, respiratory, and skin adverse events.*

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Table 1b (Table 1b)

A data table presenting adverse events occurring in 2% or more of patients treated with Meloxicam in two 12-week rheumatoid arthritis placebo-controlled trials. It compares rates of various disorders and symptoms across placebo, Meloxicam 7.5 mg daily, and Meloxicam 15 mg daily groups, including gastrointestinal, general, infection, musculoskeletal, nervous system, and skin disorders, with patient numbers listed.*

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Table 2 (Table 2)

Data table showing adverse events occurring in 2% or more of patients treated with Meloxicam 7.5 mg or 15 mg daily during 4 to 6 weeks and 6-month active-controlled osteoarthritis trials. The table categorizes events by system (gastrointestinal, body as a whole, nervous system, hematologic, musculoskeletal, psychiatric, respiratory, skin, urinary) and lists percentage incidences for each dose and trial duration.*

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Table 3 (Table 3)

Drug interaction and clinical impact information is presented related to the use of Meloxicam with various drug classes including anticoagulants, aspirin, ACE inhibitors, beta-blockers, diuretics, lithium, methotrexate, cyclosporine, NSAIDs, salicylates, and pemetrexed. The panel outlines clinical impacts and recommended interventions during concomitant use, focusing on increased risks such as bleeding, renal impairment, toxicity, and drug efficacy changes.*

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Table 4 (Table 4)

A data table presenting single dose and steady-state pharmacokinetic parameters for oral Meloxicam in 7.5 mg and 15 mg strengths. The table includes measurements for healthy male adults, elderly males and females (fed), and patients with renal failure or hepatic insufficiency (fasted). Parameters include Cmax, Tmax, half-life, clearance, and volume of distribution, with mean values and percentage coefficients of variation.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.