{"effective_time":"20100106","id":"1262af65-982c-461a-92d6-d00841a1fb99","openfda":{},"package_label_principal_display_panel":["Principal Display Panel Do not use if safety seal is broken NDC 43093-100-01 Rx only FusePaq™ Compounding Kit for Oral Suspension SYNAPRYN™ (tramadol hydrochloride 10 mg/mL, in oral suspension with glucosamine - compounding kit) When compounded according to directions, this kit makes 500 mL of an oral suspension containing 10 mg/mL tramadol hydrochloride with glucosamine Contents: 5 g tramadol hydrochloride, EP 500 mL bottle containing 250 mL flavor vehicle (purified water, glycerin, cherry flavor xanthan gum, sodium citrate, citric acid, potassium sorbate, sodium benzoate) 250 mL bottle containing 250 mL suspension vehicle (purified water, glycerin, sorbitol, glucosamine sulfate, sodium saccharin, citric acid, potassium sorbate, sodium benzoate) Bottle adaptor for oral syringe Oral syringe Instructions For Prescription Compounding Only U.S. Patents Pending Synapryn Carton Tramadol Label Suspension Label Flavor Label Insert Page 1 Insert Page 2"],"set_id":"594bad96-d0e0-4a12-8a38-762962f54a66","spl_product_data_elements":["Synapryn Tramadol Hydrochloride Tramadol Hydrochloride Tramadol Hydrochloride Tramadol Hydrochloride Tramadol Structured Suspension Vehicle Suspension Water Glycerin Sorbitol Glucosamine Sulfate Saccharin Sodium Citric Acid Potassium Sorbate Sodium Benzoate Structured Flavoring Vehicle Flavor Water Glycerin Cherry Xanthan Gum Citric Acid Sodium Citrate Potassium Sorbate Sodium Benzoate"],"spl_unclassified_section":["Drug Label Do not use if safety seal is broken Tramadol Hydrochloride [(±)-trans-2-Dimethylaminomethyl-1-(3-methoxyphenyl)cyclohexanol hydrochloride] CAUTION: For manufacturing, processing, repacking, or prescription compounding CAS #73806-49-2 Net Contents: 5 g Repackaged by Fusion Pharmaceuticals, LLC Camarillo, CA 93012 CS2-A1 rev 1","Suspension Label Do not use if safety seal is broken For Prescription Compounding Only Structured Suspension Vehicle Sugar, dye, and paraben free Contents: Purified water, glycerin, sorbitol, glucosamine sulfate, sodium saccharin, citric acid, potassium sorbate, sodium benzoate Net Contents: 250 mL (8.4 fl oz) Manufactured for: Fusion Pharmaceuticals LLC Camarillo, CA 93012 CS4-A1 rev 3","Flavor Label Do not use if safety seal is broken For Prescription Compounding Only Structured Flavoring Vehicle Sugar, Dye, and Paraben Free Contents: Purified water, glycerin USP, cherry flavor, xanthan gum, citric acid, sodium citrate, potassium sorbate, sodium benzoate Net Contents: 250 mL (8 fl oz) Manufactured for: Fusion Pharmaceuticals LLC Camarillo, CA 93012 CS7-A1 rev 2","Instructions Insert NDC 43093-100-01 Rx only FusePaq™ SYNAPRYN™ (tramadol hydrochloride 10 mg/mL, in oral suspension with glucosamine - compounding kit) FusePaq™ compounding kits provide a convenient approach to rapidly compound prescription medications, as all components are pre-measured. This kit is manufactured according to US FDA current Good Manufacturing Practice (cGMP). For Prescription Compounding Only Description: When compounded according to directions, this kit makes 500 mL of an oral suspension containing 10mg/mL tramadol hydrochloride with glucosamine. Contents: 5 g tramadol hydrochloride, EP 500 mL bottle containing 250 mL flavor vehicle (purified water, glycerin, cherry flavor, xanthan gum, sodium citrate, citric acid, potassium sorbate, sodium benzoate) 250 mL bottle containing 250 mL suspension vehicle (purified water, glycerin, sorbitol, glucosamine sulfate, sodium saccharin, citric acid, potassium sorbate, sodium benzoate) Bottle adaptor for oral syringe Oral syringe Instructions Instructions for the Pharmacist 1 Remove and Inspect the Contents of the Kit Ensure that the safety seals are present and intact on the tramadol hydrochloride, flavor, and suspension vehicle bottles. If the seals are not intact, do not use the kit. 2 Prepare for Mixing Wear gloves and eye protection during compounding operations. Remove the seals from the flavor and suspension bottles. Break the perforated seal and remove the cap from the tramadol hydrochloride bottle. 3 Transfer Tramadol Hydrochloride to the Flavor Bottle Flip the tip up on the suspension bottle cap. Squeeze a small amount of liquid suspension (approximately 10 mL) into the tramadol hydrochloride bottle. Cap the tramadol hydrochloride bottle and shake well several times. Empty the contents into the flavor bottle. Repeat this step 3 times. Visually ensure that all of the tramadol hydrochloride has been transferred to the flavor bottle. Transfer the remaining suspension vehicle into the flavor bottle. 4 Complete the Mixing Process Press the oral syringe adaptor into the flavor bottle. Recap the flavor bottle which now contains the tramadol hydrochloride, suspension, and flavor. Shake well by inverting repeatedly several times. 5 Re-label the Compounded Suspension Label the compounded suspension per the pharmacy's standard practice. Remove or obscure the flavor vehicle label, since the label is no longer accurate once compounding is completed. Store the unused kit at room temperature of 15-30C (59-86F). Once prepared, store the mixed suspension between 15-30C (59-86F). The compounded suspension is stable for at least eight weeks based upon real-time and accelerated stability studies. Each lot of suspension vehicle and flavor vehicle is tested to meet microbial limits per USP Microbial Limit Test 61. In addition, the suspension vehicle and flavor vehicle formulations have each passed the USP 51 Antimicrobial Effectiveness Test. An oral syringe is provided in the kit and may be used to facilitate accurate delivery of the suspension. U.S. Patents Pending Manufactured by: Fusion Pharmaceuticals LLC 768 Calle Plano Camarillo, CA 93012 CS16-A1 rev 4"],"version":"7"}