{"active_ingredient":["Active ingredients Purpose Belladonna 30C HPUS (less than 0.000000000001% Alkaloids, calculated) minor fever Calcarea Carbonica 30C HPUS throbbing ear pain Chamomilla 30C HPUS occasional sleeplessness and irritability Lycopodium 30C HPUS ear pain Pulsatilla 30C HPUS ear itching, pain worse at night Sulphur 30C HPUS ear pain with burning \"HPUS\" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States."],"active_ingredient_table":["<table border=\"0\" width=\"100%\"><tbody><tr><td><content styleCode=\"italics\"><content styleCode=\"bold\">Active ingredients</content></content></td><td><content styleCode=\"italics\"><content styleCode=\"bold\">Purpose</content></content></td></tr><tr><td><paragraph>Belladonna 30C HPUS</paragraph><paragraph>(less than 0.000000000001% Alkaloids, calculated)  </paragraph></td><td> minor fever</td></tr><tr><td>Calcarea Carbonica 30C HPUS</td><td>  throbbing ear pain </td></tr><tr><td>Chamomilla 30C HPUS</td><td>  occasional sleeplessness and irritability </td></tr><tr><td>Lycopodium 30C HPUS</td><td>ear pain</td></tr><tr><td>Pulsatilla 30C HPUS</td><td>  ear itching, pain worse at night </td></tr><tr><td>Sulphur 30C HPUS</td><td>ear pain with burning</td></tr></tbody></table>"],"ask_doctor":["Stop use and ask a doctor if: ■ symptoms persist for more than 48 hours or worsen. ■ any discharge from ear is present. ■ symptoms are accompanied by a fever."],"do_not_use":["Do not use you have ear tubes, damaged ear drums or after ear surgery."],"dosage_and_administration":["Directions Adults and children ages 2 years and over: ■ Tilt head sideways and apply 3-4 drops into involved ear (tip of applicator should not enter ear canal). ■ Keep head tilted for at least 2 minutes to keep drops in ear. ■ Repeat until relieved, up to 4 times per day. ■ Use as directed. ■ Do not refrigerate. ■ Shake well before using."],"effective_time":"20221212","id":"efa40953-abb8-885e-e053-2a95a90a6482","inactive_ingredient":["Inactive ingredients Citric Acid, Glycerine, Purified Water, Sodium Benzoate."],"indications_and_usage":["Uses Temporarily relieves common pain or itching from swimmer’s ear, and symptoms of other earaches after diagnosis by a physician, including: ■ ear pain or itching ■ irritability ■ minor fever"],"keep_out_of_reach_of_children":["Keep out of reach of children"],"openfda":{"brand_name":["EARACHE DROPS"],"generic_name":["BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR"],"is_original_packager":[true],"manufacturer_name":["Hyland's Inc."],"package_ndc":["54973-3172-1","54973-3172-2"],"product_ndc":["54973-3172"],"product_type":["HUMAN OTC DRUG"],"route":["AURICULAR (OTIC)"],"spl_id":["efa40953-abb8-885e-e053-2a95a90a6482"],"spl_set_id":["9b18453e-e338-4b8e-9856-85aca8c46ee1"],"substance_name":["BELLADONNA LEAF","CALCIUM CARBONATE","CHAMOMILE","LYCOPODIUM CLAVATUM SPORE","ANEMONE PATENS WHOLE","SULFUR"],"unii":["6GZW20TIOI","H0G9379FGK","FGL3685T2X","C88X29Y479","4M1169RWJD","70FD1KFU70"],"upc":["0354973751620"]},"other_safety_information":["DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL Hyland's NATURALS Earache Drops RELIEVE EAR PAIN FAST* Swimmer's Ear Cold & Flu Allergy AGES 2+ DAY & NIGHT 0.33 FL. OZ. (10 mL) HOMEOPATHIC carton"],"pregnancy_or_breast_feeding":["If pregnant or breastfeeding ask a health professional before use."],"purpose":["Purpose Temporarily relieves common pain or itching from swimmer’s ear, and symptoms of other earaches after diagnosis by a physician, including: ear pain or itching, irritability, minor fever"],"questions":["Questions? www.hylands.com or (800) 624-9659"],"recent_major_changes":["Indications and Usage Uses Temporarily relieves the symptoms of:  minor fever  ear pain or throbbing  irritability or occasional sleeplessness associated with earaches after diagnosis by a physician  common pain or itching of \"swimmer’s ear\" Temporarily relieves common pain or itching from swimmer’s ear, and other earache symptoms after diagnosis by a physician, including:  ear pain, throbbing or itching  irritability  occasional sleeplessness  minor fever","Dosage and Administration (Dirctions) ■ Shake well before using. Adults and children ages 2 years and over: Tilt head sideways and apply 3-4 drops into involved ear (tip of applicator should not enter ear canal). Keep head tilted for at least 2 minutes to keep drops in ear. Repeat until relieved, up to 4 times daily."],"set_id":"9b18453e-e338-4b8e-9856-85aca8c46ee1","spl_product_data_elements":["EARACHE DROPS belladonna leaf, calcium carbonate, chamomile, lycopodium clavatum spore, anemone patens, and sulfur CITRIC ACID MONOHYDRATE WATER SODIUM BENZOATE GLYCERIN BELLADONNA LEAF BELLADONNA LEAF CALCIUM CARBONATE CALCIUM CATION CHAMOMILE CHAMOMILE LYCOPODIUM CLAVATUM SPORE LYCOPODIUM CLAVATUM SPORE ANEMONE PATENS WHOLE ANEMONE PATENS WHOLE SULFUR SULFUR"],"spl_unclassified_section":["Drug Facts Active ingredients Purpose Belladonna 30C HPUS (less than 0.000000000001% Alkaloids, calculated) minor fever Calcarea Carbonica 30C HPUS throbbing ear pain Chamomilla 30C HPUS occasional sleeplessness and irritability Lycopodium 30C HPUS ear pain Pulsatilla 30C HPUS ear itching, pain worse at night Sulphur 30C HPUS ear pain with burning \"HPUS\" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.","Drug Facts (continued) Inactive ingredients Citric Acid, Glycerine, Purified Water, Sodium Benzoate.","*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED."],"spl_unclassified_section_table":["<table border=\"0\" width=\"100%\"><tbody><tr><td><content styleCode=\"italics\"><content styleCode=\"bold\">Active ingredients</content></content></td><td><content styleCode=\"italics\"><content styleCode=\"bold\">Purpose</content></content></td></tr><tr><td><paragraph>Belladonna 30C HPUS</paragraph><paragraph>(less than 0.000000000001% Alkaloids, calculated)  </paragraph></td><td> minor fever</td></tr><tr><td>Calcarea Carbonica 30C HPUS</td><td>  throbbing ear pain </td></tr><tr><td>Chamomilla 30C HPUS</td><td>  occasional sleeplessness and irritability </td></tr><tr><td>Lycopodium 30C HPUS</td><td>ear pain</td></tr><tr><td>Pulsatilla 30C HPUS</td><td>  ear itching, pain worse at night </td></tr><tr><td>Sulphur 30C HPUS</td><td>ear pain with burning</td></tr></tbody></table>"],"version":"9","warnings":["Warnings Keep away from eyes. Do not use you have ear tubes, damaged ear drums or after ear surgery. Stop use and ask a doctor if: ■ symptoms persist for more than 48 hours or worsen. ■ any discharge from ear is present. ■ symptoms are accompanied by a fever. If pregnant or breastfeeding ask a health professional before use. Keep out of reach of children"]}