{"active_ingredient":["Pediatric Earache Remedy Aconitum napellus 6X Belladonna 3X Chamonilla 6X Kali mur 3X Plantago major 3X Verbascum 6X"],"dosage_and_administration":["Pediatric Earache Remedy Warm up bottle by gently rolling it between your hands before use. Tilt head sideways and place 2 to 3 drops into ear. Tip of applicator should not enter ear canal. Repeat 2-3 times/day for up to 4 days, if needed, or as directed by your health care professional."],"effective_time":"20251217","id":"462ed52e-9da2-6cc3-e063-6294a90ad318","inactive_ingredient":["Pediatric Earache Remedy Grapefruit Seed Extract, Olive Leaf Extract, USP Purified Water"],"indications_and_usage":["Pediatric Earache Remedy A homeopathic combination for the temporary relief of earaches, inflammation of external and internal ear. For the temporary relief of earaches from congestion or swelling of middle ear or eustacian tubes."],"keep_out_of_reach_of_children":["Pediatric Earache Remedy Keep this and all medicines out reach of children."],"openfda":{"brand_name":["Pediatric Earache Remedy"],"generic_name":["EAR DROPS"],"is_original_packager":[true],"manufacturer_name":["Vitality Works, Inc"],"package_ndc":["64616-050-01","64616-050-02"],"product_ndc":["64616-050"],"product_type":["HUMAN OTC DRUG"],"route":["AURICULAR (OTIC)"],"spl_id":["462ed52e-9da2-6cc3-e063-6294a90ad318"],"spl_set_id":["5769ce2c-d2e1-4069-92cc-e38bee668daf"],"substance_name":["ACONITUM NAPELLUS","ATROPA BELLADONNA","POTASSIUM CHLORIDE","PLANTAGO MAJOR","MATRICARIA RECUTITA","VERBASCUM THAPSUS"],"unii":["U0NQ8555JD","WQZ3G9PF0H","660YQ98I10","W2469WNO6U","G0R4UBI2ZZ","C9TD27U172"],"upc":["0019277000569"]},"package_label_principal_display_panel":["Pediatric Earache Remedy Label Carton"],"purpose":["Pediatric Earache Remedy Aconitum napellus - relieves earach, hot, painful, swollen ear. Belladonna - relieves otitis media, throbbing deep ear pain. Chamomilla - relieves earache, soreness, swelling, otalgia. Kali mur - relieves chronic catarrahal conditions of middle ear. Plantago major - relieves earache, neuralgic earache, otalgia Verbascum - Relieves catarrhs, otalgia with sense of obstruction."],"set_id":"5769ce2c-d2e1-4069-92cc-e38bee668daf","spl_product_data_elements":["Pediatric Earache Remedy Ear Drops GRAPEFRUIT OLEA EUROPAEA LEAF WATER ACONITUM NAPELLUS ACONITUM NAPELLUS ATROPA BELLADONNA ATROPA BELLADONNA POTASSIUM CHLORIDE POTASSIUM CATION PLANTAGO MAJOR PLANTAGO MAJOR MATRICARIA RECUTITA MATRICARIA RECUTITA VERBASCUM THAPSUS VERBASCUM THAPSUS"],"version":"9","warnings":["Pediatric Earache Remedy Keep this and all medicines out of reach of children. Before use with children under 3 years of age, or if you are pregnant or nursing, seek the advice of you health care professional. Avoid contact with eyes. If symptoms persist for more than 4 days, or if there is discharge from the ear or perforation, discontinue use and contact your health care professional. In case of accidental overdose, seek professional assistance or contact a poison control center immediately. All the ingredients are edible but they are not intended for internal use."]}