{"active_ingredient":["ACTIVE INGREDIENTS: (in each drop): 12.48% of Belladonna 12X, Calcarea Carbonica 12X, Chamomilla 12X, Ferrum Phosphoricum 12X, Hydrastis Canadensis 6X, Mercurius Solubilis 12X, Phytolacca Decandra 6X, Pulsatilla (Pratensis) 12X; 0.10% of Baptisia Tinctoria 3X, Echinacea Angustifolia 3X."],"dosage_and_administration":["DIRECTIONS: Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 4 days, consult your health care professional. Consult a physician for use in children under 12 years of age."],"effective_time":"20241029","id":"16dcd12c-ba0d-4cb5-afec-6de76a1bbfae","inactive_ingredient":["INACTIVE INGREDIENTS: Demineralized water, 20% Ethanol."],"indications_and_usage":["INDICATIONS: May temporarily relieve mild ear disorders with soreness, sticking pain in ear, and minor swelling of the ear with redness.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."],"keep_out_of_reach_of_children":["KEEP OUT OF REACH OF CHILDREN: Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."],"openfda":{"brand_name":["Ototone"],"generic_name":["BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, BELLADONNA, CALCAREA CARBONICA, CHAMOMILLA, FERRUM PHOSPHORICUM, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS)"],"is_original_packager":[true],"manufacturer_name":["Energique, Inc."],"package_ndc":["44911-0467-1"],"product_ndc":["44911-0467"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"spl_id":["16dcd12c-ba0d-4cb5-afec-6de76a1bbfae"],"spl_set_id":["c34e0abf-02d8-4dee-a89b-3f61ab593dc3"],"substance_name":["BAPTISIA TINCTORIA ROOT","ECHINACEA ANGUSTIFOLIA WHOLE","GOLDENSEAL","PHYTOLACCA AMERICANA ROOT","ATROPA BELLADONNA","OYSTER SHELL CALCIUM CARBONATE, CRUDE","MATRICARIA CHAMOMILLA WHOLE","FERROSOFERRIC PHOSPHATE","MERCURIUS SOLUBILIS","PULSATILLA PRATENSIS WHOLE"],"unii":["5EF0HWI5WU","VB06AV5US8","ZW3Z11D0JV","11E6VI8VEG","WQZ3G9PF0H","2E32821G6I","G0R4UBI2ZZ","91GQH8I5F7","324Y4038G2","8E272251DI"],"upc":["0363113701616"]},"package_label_principal_display_panel":["PACKAGE LABEL DISPLAY: ENERGIQUE SINCE 1987 HOMEOPATHIC REMEDY OTOTONE 1 fl. oz. (30 ml) Ototone"],"purpose":["INDICATIONS: May temporarily relieve mild ear disorders with soreness, sticking pain in ear, and minor swelling of the ear with redness.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."],"questions":["QUESTIONS: Dist. by Energique, Inc. 201 Apple Blvd Woodbine, IA 51579 800.869.8078"],"set_id":"c34e0abf-02d8-4dee-a89b-3f61ab593dc3","spl_product_data_elements":["Ototone Baptisia Tinctoria, Echinacea (Angustifolia), Hydrastis Canadensis, Phytolacca Decandra, Belladonna, Calcarea Carbonica, Chamomilla, Ferrum Phosphoricum, Mercurius Solubilis, Pulsatilla (Pratensis) BAPTISIA TINCTORIA ROOT BAPTISIA TINCTORIA ROOT ECHINACEA ANGUSTIFOLIA WHOLE ECHINACEA ANGUSTIFOLIA GOLDENSEAL GOLDENSEAL PHYTOLACCA AMERICANA ROOT PHYTOLACCA AMERICANA ROOT ATROPA BELLADONNA ATROPA BELLADONNA OYSTER SHELL CALCIUM CARBONATE, CRUDE OYSTER SHELL CALCIUM CARBONATE, CRUDE MATRICARIA CHAMOMILLA WHOLE MATRICARIA CHAMOMILLA FERROSOFERRIC PHOSPHATE FERROSOFERRIC PHOSPHATE MERCURIUS SOLUBILIS MERCURIUS SOLUBILIS PULSATILLA PRATENSIS WHOLE PULSATILLA PRATENSIS WHOLE WATER ALCOHOL"],"version":"3","warnings":["WARNINGS: If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Do not use if tamper evident seal is broken or missing. Store in a cool, dry place."]}