Tizanidine
Product Images NDC 71610-355

6 FDA label images from Aphena Pharma Solutions - Tennessee, Llc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Tizanidine (NDC 71610-355). 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.

Product Images & Figures Index

FDA Label Image

Bottle Label 4 mg (71610 0355 30)

Bottle Label 4 mg (71610 0355 30)
tizanidine 4 mg tablets packaging label by Aphena Pharma Solutions - Tennessee, LLC. The label indicates the product contains 30 tablets, with storage instructions between 20-25 degrees Celsius and a note to keep the medication out of reach of children. Manufacturer is Apotex Inc., Toronto, Canada, with repackaging by Aphena Pharma Solutions in Cookeville, Tennessee. The label includes NDC 71610-355-30, barcodes, and other regulatory text.*
FDA Label Image

Aphena Pharma Solutions (TN)

Aphena Pharma Solutions (TN)
FDA Label Image

Figure-1.jpg (Figure 1)

Figure-1.jpg (Figure 1)
Line graph showing mean tizanidine concentration over time for 2 x 4 mg tizanidine tablets and capsules under fasted and fed conditions. The x-axis represents hours from dosing, and the y-axis shows plasma tizanidine concentration in ng/mL, illustrating absorption and elimination profiles.*
FDA Label Image

Figure-2.jpg (Figure 2)

Figure-2.jpg (Figure 2)
A line chart titled 'Single Dose Study—Mean Change in Muscle Tone from Baseline as Measured by the Ashworth Scale ± 95% Confidence Interval.' The chart compares muscle tone improvement over 6 hours post-dose for three groups: 16 mg tizanidine, 8 mg tizanidine, and placebo. The y-axis represents improvement in Ashworth Score, where a negative score denotes improvement, and the x-axis shows hours post-dose from 0 to 6.*
FDA Label Image

Figure-3.jpg (Figure 3)

Figure-3.jpg (Figure 3)
A line graph titled 'Seven Week Study—Mean Change in Muscle Tone 0.5 to 2.5 Hours After Dosing,' comparing tizanidine (mean dose 28.8 mg) and placebo groups over three time points: End of Titration (Week 3), End of Maintenance (Week 7), and Endpoint (Last Observation Carried Forward). The y-axis shows improvement in Ashworth Score with a negative score indicating improvement in muscle tone. Tizanidine group exhibits greater improvement than placebo at all measured time points, with 95% confidence intervals shown for each.*
FDA Label Image

Chemical-structure (Tizanidine Imtb 01)

Chemical-structure (Tizanidine Imtb 01)
Chemical structure diagram of tizanidine hydrochloride, showing its molecular configuration with a chlorinated ring and attached heterocyclic groups.*

* 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.