Image Description (Figure2)
Tramadol Hydrochloride
Product Images NDC 61919-583
View Photos of Packaging, Regulatory Labels, and Product Appearance
Product Visual Gallery
This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Tramadol Hydrochloride (NDC 61919-583). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Direct Rx, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.
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Image Description (Table1)
The text describes a table (Table 1) that shows the incidence of adverse reactions in patients with chronic pain who participated in four double-blind, placebo-controlled studies. The studies used an extended-release form of tramadol hydrochloride, and the table displays the percentages of patients who experienced adverse reactions greater than 5% at different doses. The adverse reactions listed in the table include headache, nausea, somnolence, dizziness, constipation, vomiting, arthralgia, dry mouth, sweating, asthenia, pruritus, anorexia, and insomnia.*
Image Description (Table2)
The text provides information on dosage for immediate-release and extended-release medications. The dosages listed are 150 mg for immediate-release, 37.5 mg for immediate-release, and 1125 mg for extended-release.*
Image Description (Table3)
Table 2 shows the steady-state pharmacokinetic parameter values of Tramadol and O-Desmethyl-Tramadol (M1 Metabolite) in extended-release capsules. The table presents the mean and coefficient of variation (%CV) of different parameters such as AUCO-24, Cmax, Crmin, and Tmax for both Tramadol hydrochloride and the reference drug. The study was conducted on a sample size of 38 patients taking 200mg capsules of extended-release tramadol. This information can be useful for healthcare professionals in determining the pharmacokinetic properties of Tramadol extended-release capsules.*
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.
