{"active_ingredient":["Active ingredient Sodium carboxymethylcellulose 0.25%"],"do_not_use":["Do not use if solution changes color or becomes cloudy."],"dosage_and_administration":["Directions To open, twist tab completely off. Instill 1 or 2 drops of TheraTears® EXTRA® in the affected eye(s) as needed"],"effective_time":"20241213","id":"ca0d40e7-168e-40a9-8df0-3e8958cdb7cf","inactive_ingredient":["Inactive ingredients Boric acid, calcium chloride, hydrochloric acid*, magnesium chloride, potassium chloride, sodium bicarbonate, sodium borate, sodium chloride, sodium hydroxide*, sodium phosphate, trehalose, and water for injection. *May contain these ingredients to adjust pH."],"indications_and_usage":["Uses For use as a protectant against further irritation or to relieve dryness of the eye. For use as a lubricant to prevent further irritation or to relieve dryness of the eye."],"keep_out_of_reach_of_children":["Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M018"],"brand_name":["TheraTears Extra"],"generic_name":["CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED"],"is_original_packager":[true],"manufacturer_name":["MEDTECH PRODUCTS INC"],"package_ndc":["58790-010-30"],"product_ndc":["58790-010"],"product_type":["HUMAN OTC DRUG"],"route":["OPHTHALMIC"],"rxcui":["1547948","2106821"],"spl_id":["ca0d40e7-168e-40a9-8df0-3e8958cdb7cf"],"spl_set_id":["f1845041-9d8d-42a0-a2cb-68def7a5aac7"],"substance_name":["CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED"],"unii":["K679OBS311"]},"other_safety_information":["Other information Use only if foil pouch is sealed and single-use container is intact. Do not touch unit-dose tip to eye."],"package_label_principal_display_panel":["Principal Display Panel Text for Carton Label: PRESERVATIVE FREE RECOMMENDED DOCTOR CREATED thera tears® THERAPY FOR YOUR EYES® EXTRA® dry eye therapy LUBRICANT EYE DROPS EXTRA MOISTURIZING √ Rehydrates √ Protects √ Supports pH Level 30 STERILE Single-Use Vials 0.60 FL OZ (18.0 mL) TOTAL Principal Display Panel Text for Carton Label: PRESERVATIVE FREE RECOMMENDED DOCTOR CREATED thera tears® THERAPY FOR YOUR EYES® EXTRA® dry eye therapy LUBRICANT EYE DROPS EXTRA MOISTURIZING √ Rehydrates √ Protects √ Supports pH Level 30 STERILE Single-Use Vials 0.60 FL OZ (18.0 mL) TOTAL"],"purpose":["Purpose Eye lubricant"],"questions":["Questions or comments? 1-800-579-8327"],"set_id":"f1845041-9d8d-42a0-a2cb-68def7a5aac7","spl_product_data_elements":["TheraTears Extra Carboxymethylcellulose Sodium, Unspecified Carboxymethylcellulose Sodium, Unspecified Carboxymethylcellulose Boric Acid calcium chloride hydrochloric acid magnesium chloride potassium chloride sodium bicarbonate sodium borate sodium chloride sodium hydroxide sodium phosphate trehalose water"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask a doctor if you experience eye pain, changes in vision, continued redness or irritation. condition worsens or persists for more than 72 hours."],"version":"4","warnings":["Warnings For external use only To avoid contamination, do not touch tip of opened container to any surface. Do not reuse. Once opened discard. Use individual vials within 90 days of opening foil pouch. This product contains no preservatives. Any solution not used immediately after opening should he discarded. Re-use of this single-use product may lead to inflammation of the eye and/or discomfort, based on potential contamination during handling. Do not use if solution changes color or becomes cloudy. Stop use and ask a doctor if you experience eye pain, changes in vision, continued redness or irritation. condition worsens or persists for more than 72 hours. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."]}