{"active_ingredient":["OTC - ACTIVE INGREDIENT Sodium Chloride, USP 0.9% (0.027 mg per 1 mL)"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Directions for use: To verify container integrity, squeeze the vial before use. Twist cap completely off vial, invert and squeeze prescribed volume. Discard any unused portion of the contents of this single-use vial as well as any unused solution remaining in the nebulizer cup."],"effective_time":"20221215","id":"2bd40a34-c13c-47e1-9e12-aea138f988ed","inactive_ingredient":["INACTIVE INGREDIENT Water for Injection, USP"],"indications_and_usage":["INDICATIONS AND USAGE Intended for use in respiratory therapy or for tracheal or lavage. This sterile, single-use device is intended to be used as an accessory to medicinal nonventilatory nebulizers for respiratory therapy or for tracheal irrigation or lavage therapy."],"keep_out_of_reach_of_children":["OTC - KEEP OUT OF REACH OF CHILDREN Keep out of reach of children. RX ONLY"],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL Sodium Chloride Inhalation Solution, USP, 0.9% 5 x 3 ml Unit-Dose Vials Each in a foil pouch bag label"],"purpose":["OTC - PURPOSE Sterile, non-pyrogenic, preservative-free single-use vials for respiratory therapy. No bacteriostatic agent or other preservative added."],"set_id":"8f14bf79-c6ee-4f4f-8540-1941d7fe3241","spl_product_data_elements":["Sodium Chloride Sodium Chloride SODIUM CHLORIDE SODIUM CATION WATER"],"spl_unclassified_section":["HOW SUPPLIED Sodium Chloride Inhalation Solution, 0.9% is supplied in single-use plastic vials in the following configurations. NDC 55154-4358-5 overbagged with 5 x 3 mL vial per bag Internal contents sterile. External surface of vial not sterile. Storage and Handling Store at controlled room temperature 15° to 30°C (59° to 86°F). Nephron Pharmaceuticals Corporation West Columbia, SC 29172 For Customer Service, Call 1-800-443-4313 Email: Customerservice@nephronpharm.com Made in the USA Distributed By: Cardinal Health Dublin, OH 43017 L44920210519"],"storage_and_handling":["Storage and Handling Store at controlled room temperature 15° to 30°C (59° to 86°F). Nephron Pharmaceuticals Corporation West Columbia, SC 29172 For Customer Service, Call 1-800-443-4313 Email: Customerservice@nephronpharm.com Made in the USA Distributed By: Cardinal Health Dublin, OH 43017 L44920210519"],"version":"12","warnings":["WARNINGS Not for injection or in preparations to be used for injection. This device is not for parenteral use or for preparations intended for parenteral use. CAUTION: Contents are sterile in the unopened, undamaged package."]}