Label: CHILDRENS EARACHE RELIEF- aconitum napellus, allium capa, apis mellifica, belladonna, calcarea carbonica, capsicum annuum, causticum, chamomilla, dulcamara, ferrum phosphoricum, hepar sulphuris calcareum, kali muriaticum, mercurius dulcis, mercurius solubilis, plantago major, and silicea liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 57955-5315-2 - Packager: King Bio Inc.
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated April 13, 2012
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Active Ingredients
Official HPUS: Aconitum napellus, Allium capa, Apis mellifica, Belladonna, Calcarea carbonica, Capsicum annuum, Causticum, Chamomilla, Dulcamara, Ferrum phosphoricum, Hepar sulphuris calcareum, Kali muriaticum, Mercurius dulcis, Mercurius solubilis, Plantago major, and Silicea.
Reference image childrens earache.jpg
- Inactive Ingredient
- Dosage and Administration
- Purpose
- Warnings
- KEEP OUT OF REACH OF CHILDREN
- Indications and Usage
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CHILDRENS EARACHE RELIEF
aconitum napellus, allium capa, apis mellifica, belladonna, calcarea carbonica, capsicum annuum, causticum, chamomilla, dulcamara, ferrum phosphoricum, hepar sulphuris calcareum, kali muriaticum, mercurius dulcis, mercurius solubilis, plantago major, and silicea liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57955-5315 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 10 [hp_X] in 59 mL ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION 10 [hp_X] in 59 mL APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA 10 [hp_X] in 59 mL ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 10 [hp_X] in 59 mL OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE 10 [hp_X] in 59 mL CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM 10 [hp_X] in 59 mL CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM 10 [hp_X] in 59 mL MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 10 [hp_X] in 59 mL SOLANUM DULCAMARA TOP (UNII: KPS1B1162N) (SOLANUM DULCAMARA TOP - UNII:KPS1B1162N) SOLANUM DULCAMARA TOP 10 [hp_X] in 59 mL FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERRIC CATION - UNII:91O4LML611) FERROSOFERRIC PHOSPHATE 10 [hp_X] in 59 mL CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM SULFIDE 10 [hp_X] in 59 mL POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CHLORIDE 10 [hp_X] in 59 mL CALOMEL (UNII: J2D46N657D) (CALOMEL - UNII:J2D46N657D) CALOMEL 10 [hp_X] in 59 mL MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS 10 [hp_X] in 59 mL PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR 10 [hp_X] in 59 mL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 10 [hp_X] in 59 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57955-5315-2 59 mL in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/01/2011 Labeler - King Bio Inc. (617901350) Registrant - King Bio Inc. (617901350) Establishment Name Address ID/FEI Business Operations King Bio Inc. 617901350 manufacture