{"active_ingredient":["Active ingredients Purpose Belladonna 30C HPUS (less than 0.0000000000001 % Alkaloids, calculated) 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 the active ingredients are in the official Homeopathic Pharmacopœia of the United States"],"active_ingredient_table":["
Active ingredientsPurpose
Belladonna 30C HPUS(less than 0.0000000000001 % Alkaloids, calculated)fever
Calcarea Carbonica 30C HPUSthrobbing ear pain
Chamomilla 30C HPUSoccasional sleeplessness and irritability
Lycopodium 30C HPUSear pain
Pulsatilla 30C HPUSear itching, pain worse at night
Sulphur 30C HPUSear pain with burning
"],"ask_doctor":["Consult a physician if: ■ symptoms persist for more than 48 hours or worsen. ■ discharge from ear is present. ■ symptoms are accompanied by a high fever (over 101°F)."],"do_not_use":["Do not use if you have ear tubes, damaged ear drums or after ear surgery."],"dosage_and_administration":["Directions ■Shake well before using. Children under 6 months Consult a physician. Children 6 months 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."],"dosage_and_administration_table":["
Children under 6 months Consult a physician.
Children 6 months 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.
"],"effective_time":"20250415","id":"32d9b834-a68e-dd32-e063-6294a90a37ea","inactive_ingredient":["Inactive ingredients Citric Acid,Glycerine, Purified Water, Sodium Benzoate."],"indications_and_usage":["Uses ■ Temporarily relieves symptoms of earache in children after diagnosis by a physician, including: ■ minor fever ■ ear pain or throbbing ■ irritability ■ occasional sleeplessness ■ common pain or itching of \"swimmer’s ear\""],"keep_out_of_reach_of_children":["Keep this and all medications out of the reach of children."],"openfda":{},"other_safety_information":["Other information ■ Do not use if imprinted \"SEALED FOR YOUR PROTECTION\" tamper-evident bottle cap band is broken or missing. ■ Store at room temperature. ■ Do not refrigerate."],"package_label_principal_display_panel":["PACKAGE LABEL-PRINCIPAL DISPLAY PANEL HOMEOPATHIC NDC 54973-7516-3 6+ months NEW LOOK BABY SINCE 1903 Hyland's Infant Earache Drops* Relieves earache due to cold, flu, allergy and swimmer's ear NO DYES or PARABENS NO NUMBING EFFECT Natural Relief 0.33 FL.OZ. (10mL) *SEE NOTE ON SIDE PANEL BELOW DRUG FACTS Carton"],"purpose":["■ Temporarily relieves symptoms of earache in children after diagnosis by a physician, including: ■ minor fever ■ ear pain or throbbing ■ irritability ■ occasional sleeplessness ■ common pain or itching of \"swimmer’s ear\""],"questions":["Questions or comments? (800) 624-9659"],"recent_major_changes":["Indications and Usage (Uses) ■ Temporarily relieves symptoms of earache in children after diagnosis by a physician, including: ■ minor fever ■ ear pain or throbbing ■ irritability ■ occasional sleeplessness ■ common pain or itching of \"swimmer’s ear\"","Dosage and Administration ■ Shake well before using. Children under 6 months Consult a physician. Children 6 months 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."],"recent_major_changes_table":["
Children under 6 months Consult a physician.
Children 6 months 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":"d3f3c5c8-c723-4665-aa3b-2da62d68d258","spl_product_data_elements":["BABY INFANT EARACHE DROPS belladonna leaf, calcium carbonate, chamomile, lycopodium clavatum spore, anemone patens, and sulfur WATER CITRIC ACID MONOHYDRATE SODIUM BENZOATE GLYCERIN BELLADONNA LEAF BELLADONNA LEAF CALCIUM CARBONATE CALCIUM CATION CHAMOMILE CHAMOMILE LYCOPODIUM CLAVATUM SPORE LYCOPODIUM CLAVATUM SPORE PULSATILLA PATENS WHOLE PULSATILLA PATENS WHOLE SULFUR SULFUR"],"spl_unclassified_section":["Drug Facts Active ingredients Purpose Belladonna 30C HPUS (less than 0.0000000000001 % Alkaloids, calculated) 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 the active ingredients are in the official Homeopathic Pharmacopœia of the United States","Drug Facts (continued) Other information ■ Do not use if imprinted \"SEALED FOR YOUR PROTECTION\" tamper-evident bottle cap band is broken or missing. ■ Store at room temperature. ■ Do not refrigerate.","*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED."],"spl_unclassified_section_table":["
Active ingredientsPurpose
Belladonna 30C HPUS(less than 0.0000000000001 % Alkaloids, calculated)fever
Calcarea Carbonica 30C HPUSthrobbing ear pain
Chamomilla 30C HPUSoccasional sleeplessness and irritability
Lycopodium 30C HPUSear pain
Pulsatilla 30C HPUSear itching, pain worse at night
Sulphur 30C HPUSear pain with burning
"],"version":"8","warnings":["Warnings Keep away from eyes. Do not take by mouth. Earache drops are only to be used in the ears. Do not use if you have ear tubes, damaged ear drums or after ear surgery. Consult a physician if: ■ symptoms persist for more than 48 hours or worsen. ■ discharge from ear is present. ■ symptoms are accompanied by a high fever (over 101°F). Keep this and all medications out of the reach of children. If swallowed contact a medical professional or Poison Control Center immediately. Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659."]}