Tabradol
Product Images NDC 43093-101

This is a Structured Product Label File for Cyclobenzaprine Hydrochloride in a 0.25 g packaging. The label includes instructions not to use if safety seal is broken, and indicates that it is a prescription-only medication. The drug listing file was repackaged by Fusion Pharmaceuticals, located in Camarillo, CA. The CAS number listed is 6202-23-9.*

ABRADOL is an FDA-approved oral suspension medication containing cyclobenzaprine hydrochloride, and comes in a FusePaq B kit. The product is produced by Fusion Pharmaceuticals LLC and is only available with a prescription. The kit should be stored at 15-30°C (59-86°F). The medication is formulated by a licensed medical professional, containing active and inactive ingredients, including xanthan gum, potassium sorbate, and cherry flavor. It is recommended to use the medication only when safe and as directed by the physician. The product is suitable for patients desiring medication that is personalized to their needs.*

This is a Structured Product Label Form for Drug Listing. It is suggested not to use the product if safety seal is broken. The product is a Structured Suspension Vehicle, which is free from sugar, dye, and paraben. The contents of the product include purified water, MSM, glycerin, sorbitol, sodium saccharin, citric acid, potassium sorbate, and sodium benzoate. The net contents of the product are 125 mL (4.2 fl oz) and it is a Pharmaceutical product manufactured for Fusion Pharmaceuticals LLC located in Camarillo, CA. The date of creation of this label is August 4th, 2014.*

This kit allows the preparation of 2560 mL of an oral suspension containing 1 mg/mL cyclobenzaprine hydrochloride with MSM. The kit includes a specific amount of cyclobenzaprine hydrochloride, flavor vehicle, suspension vehicle, bottle adaptor for oral syringe, oral syringe, and instructions for the pharmacist. The pharmacist needs to ensure that the safety seals are present and intact on the medication bottles before compounding. The cyclobenzaprine hydrochloride is mixed with the suspension in the flavor bottle, shaken well, and then labeled according to the pharmacy's standard practice. The resulting final suspension is stable for at least eight weeks. An oral syringe is provided with the kit to ensure accurate delivery of the medication.*

This is a description of a Structured Product Label Form for a prescription medication called FusePaq i TABRADOL. It contains cyclobenzaprine hydrochloride and is provided in kit form, with pre-measured components, including a bottle adaptor and oral syringe. The kit, when prepared according to directions, produces a 250mL oral suspension containing 1mg/mL of cyclobenzaprine hydrochloride and MSM, which is intended for use by pharmacists to quickly and easily prepare prescriptions. This kit is manufactured according to US FDA current Good Manufacturing Practice (cGMP).*

This text provides instructions for pharmacists to prepare a final oral suspension of Cyclobenzaprine Hydrochloride with MSM, using a kit labeled "Fuse 'ly TABRADOL". The text instructs pharmacists on how to transfer the cyclobenzaprine hydrochloride powder from the kit to a flavor bottle using a liquid suspension vehicle. The preparation process is then completed with instructions to label the final product and store it at room temperature. The resulting final suspension is said to be stable for at least eight weeks based on laboratory testing.*