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

Childrens Earache Relief by

Drug Labeling and Warnings

Childrens Earache Relief by is a Homeopathic medication manufactured, distributed, or labeled by King Bio Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Equal volumes of each ingredient in a Bio-Energetically Enhanced pure water base: 10X, 30X, and LM1 potencies.

Reference image childrens earache.jpg

Dosage and Administration

Directions: Initially, depress pump until primed. Hold close to mouth and spray one dose directly into mouth. Use 3 times per day. Use additionally as needed.

Adult Dose 3 pump sprays

Children 2-12 years 2 pump sprays

Reference image childrens earache.jpg

Purpose

Uses for fast relief of earache symptoms:

• ear pain
• inflammation
  
• discharge
• fever
• congestion
• sensitivity to noise
• ringing
• throbbing
• buzzing
• humming

Reference image childrens earache.jpg

Warnings

If symptoms persist or worsen, or if pregnant or nursing, take only on advice of a healthcare professional. Keep out of reach of children.

Other: Tamper resistant for your protection. Use only if safety seal is intact.

Reference image childrens earache.jpg

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

Reference image childrens earache.jpg

Indications and Usage

Uses for fast relief of earache symptoms: ear pain, inflammation, discharge, fever, congestion, sensitivity to noise, ringing, throbbing, buzzing, and humming.

Reference image childrens earache.jpg

PRINCIPAL DISPLAY PANEL

King Bio Inc.

3 Westside Drive

Asheville, NC 28806

Questions? Call 800.543.3245

www.kingbio.com

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 liquid

Product 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