Tizanidine Tablet
Product Images NDC 43063-455

5 FDA label images from Pd-rx Pharmaceuticals, Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 5 technical images submitted to the FDA as part of the official labeling for Tizanidine (NDC 43063-455). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Pd-rx Pharmaceuticals, Inc., 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

Image (43063455)

Image (43063455)
Label for Tizanidine 4 mg tablets by PD-Rx Pharmaceuticals, Inc. The label indicates the package contains 60 oral tablets, with NDC 43063-455-60. It features the brand and generic name "Tizanidine USP" prominently, dosage strength (4 mg), quantity, expiration date 06/2021, lot number F19E31, and reorder number 104418. The label includes warnings about drowsiness, storage instructions, and FDA side effect reporting information. There is a barcode and a QR code on the label.*
FDA Label Image

Fig1 (Fig1)

Fig1 (Fig1)
A pharmacokinetic graph depicting plasma tizanidine concentration (ng/mL) over time (hours) from dosing. It compares plasma levels of 2 x 4 mg tizanidine tablets and capsules taken with and without food within 24 hours post-dose, showing differences in concentration peaks and elimination over time.*
FDA Label Image

Fig2 (Fig2)

Fig2 (Fig2)
A line graph showing improvement in Ashworth Score over 6 hours post-dose, comparing 16 mg tizanidine, 8 mg tizanidine, and placebo. The vertical axis represents improvement in Ashworth Score, while the horizontal axis is hours post-dose. The 16 mg dose shows the highest peak improvement around 2 hours, followed by 8 mg, and placebo shows minimal improvement.*
FDA Label Image

Fig3 (Fig3)

Fig3 (Fig3)
A line graph depicting the improvement in Ashworth Score over time for tizanidine and placebo groups. The x-axis shows study milestones: End of Titration (Week 3), End of Maintenance (Week 7), and Endpoint (Last Observation Carried Forward). The y-axis represents improvement in Ashworth Score, with values ranging from -6 to 2. Mean dose for tizanidine is noted as 28.8 mg.*
FDA Label Image

Structure (Structure)

Structure (Structure)
Chemical structure of Tizanidine hydrochloride showing its fused ring system and molecular arrangement.*

* 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.