71610 0583 15
Meloxicam Tablet
Product Images NDC 71610-583
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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.
Adverse Reactions (Adverse Reactions)
This text appears to be a list of various side effects or symptoms that may be experienced in relation to different bodily systems, such as cardiovascular, respiratory, gastrointestinal, and urinary. Some examples include allergic reactions, weight changes, hypertension, vertigo, gastric ulcers, abnormal heart rate, anemia, liver issues, and urinary problems. It also mentions psychiatric symptoms such as depression and somnolence. The text may be a compilation of potential adverse effects of a particular medication or health condition.*
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Structure (Struct)
Table 1a (Table 1a)
The text describes adverse events occurring in patients taking different doses of meloxicam and diclofenac in a 12-week osteoarthritis trial. The table provides a breakdown of the percentage of patients experiencing adverse events for each medication, including gastrointestinal problems, body-wide effects, nervous system effects, and skin issues. The table reveals that meloxicam at 15mg and 100mg daily reported the highest number of adverse events in most categories. The text provides aggregated results based on WHO-preferred terms for some adverse events.*
Table 1b (Table 1b)
The table shows the adverse events (%) experienced by more than 2% of Meloxicam patients in two 12-week placebo-controlled trials conducted for Rheumatoid Arthritis. The Meloxicam patients were divided into two sub-groups - one received 7.5 mg/day and the other 15 mg/day. The adverse events are classified as per the body system affected. The adverse events included gastrointestinal disorders, infections and infestations, musculoskeletal and connective tissue disorders, and nervous system disorders, among others. The most common symptoms were dyspepsia, nausea, joint pain, headache, and rash.*
Table 2 (Table 2)
Table 3 (Table 3)
Table 4 (Table 4)
This is a table that presents pharmacokinetic parameters for oral 7.5mg and 15mg Meloxicam, including steady-state and single dose pharmacokinetics in healthy adults and elderly males and females without renal or hepatic insufficiency, but also in elderly and renal or hepatic insufficiency patients. The table includes multiple parameter values obtained from various studies. The studies were not conducted under high fat conditions. The Meloxicam administered was in the form of tablets and capsules.*
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.
