{"active_ingredient":["Active ingredients (in each drop)"],"dosage_and_administration":["Directions for adults and children over 6 months of age tilt head sideways and apply 3-4 drops into the affected ear up to 4 times daily. Tip of dropper should not enter ear canal. To keep drops in, tilt ear upward after application or gently place cotton in the ear. children under 6 months of age consult a doctor"],"dosage_and_administration_table":["<table><col width=\"84\"/><col width=\"229\"/><tbody><tr><td styleCode=\"Rrule \">for adults and children over 6 months of age</td><td styleCode=\"Lrule \">tilt head sideways and apply 3-4 drops into the affected ear up to 4 times daily. Tip of dropper should not enter ear canal. To keep drops in, tilt ear upward after application or gently place cotton in the ear.</td></tr><tr><td styleCode=\"Toprule Rrule \">children under 6 months of age</td><td styleCode=\"Toprule Lrule \">consult a doctor</td></tr></tbody></table>"],"effective_time":"20230307","id":"88353f85-2581-4372-a83a-efb73c4d07cf","inactive_ingredient":["Inactive ingredients chamomile (flower) extract, citric acid, glycerin, purified water, sodium benzoate"],"indications_and_usage":["Uses may help with the irritation of clogged ears by relieving the sense of discomfort in the ear, sensitivity to earwax and drafts."],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away."],"openfda":{},"other_safety_information":["Other information Do not use if white neck band imprinted with \"SEALED FOR YOUR PROTECTION\" is broken or missing. Keep carton for full drug facts."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 29.6 mL Bottle Carton Auro ® Homeopathic* Ear Relief Drops May help ease symptoms of clogged ears Long lasting relief Safe for daily use For children over 6 months 1FL OZ (29.6 mL) PRINCIPAL DISPLAY PANEL - 29.6 mL Bottle Carton Auro® Homeopathic* Ear Relief Drops • May help ease symptoms of clogged ears • Long lasting relief • Safe for daily use • For children over 6 months 1FL OZ (29.6 mL)"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding ask a doctor before use."],"purpose":["Purpose Belladonna 18X hardness of hearing Calcarea carbonica 12X discomfort in ear Capsicum annuum 6X pressure in ear Chamomilla 15X calmative Kali bichromicum 12X tickling Plantago major 4X sensitivity to discomfort Verbascum thapsus 4X clogging"],"purpose_table":["<table><col width=\"191\"/><col width=\"193\"/><tbody><tr><td styleCode=\"Toprule \">Belladonna 18X</td><td styleCode=\"Toprule \" align=\"right\">hardness of hearing</td></tr><tr><td>Calcarea carbonica 12X</td><td align=\"right\">discomfort in ear</td></tr><tr><td>Capsicum annuum 6X</td><td align=\"right\">pressure in ear</td></tr><tr><td>Chamomilla 15X</td><td align=\"right\">calmative</td></tr><tr><td>Kali bichromicum 12X</td><td align=\"right\">tickling</td></tr><tr><td>Plantago major 4X</td><td align=\"right\">sensitivity to discomfort</td></tr><tr><td>Verbascum thapsus 4X</td><td align=\"right\">clogging</td></tr></tbody></table>"],"questions":["Questions? call 1-800-344-7239 Distributed by: INSIGHT Pharmaceuticals, LLC. Trevose, PA 19053-8433"],"set_id":"788ccc23-2abf-48ce-9d97-9283980b18ec","spl_product_data_elements":["Auro Homeopathic Ear Relief Drops Atropa Belladonna, Oyster Shell Calcium Carbonate, Crude, Capsicum, Matricaria Recutita, Potassium Dichromate, Plantago Major, and Verbascum Thapsus Atropa Belladonna Atropa Belladonna Oyster Shell Calcium Carbonate, Crude Oyster Shell Calcium Carbonate, Crude Capsicum Capsicum Matricaria Recutita Matricaria Recutita Potassium Dichromate Dichromate Ion Plantago Major Plantago Major Verbascum Thapsus Verbascum Thapsus Chamomile Citric Acid Monohydrate Glycerin Sodium Benzoate Water"],"spl_unclassified_section":["Auro ® Earache Drug Facts"],"stop_use":["Stop use and ask a doctor if symptoms persist for more than 48 hours there is discharge from the ear there is a fever of 102°F or greater"],"version":"3","warnings":["Warnings Do not take by mouth. Ear drops are only to be used in the ears. Do not use with ear tubes. Stop use and ask a doctor if symptoms persist for more than 48 hours there is discharge from the ear there is a fever of 102°F or greater If pregnant or breast-feeding ask a doctor before use. Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away."]}