HOMEOPATHIC EAR ACHE FORMULA- aconitum napellus, belladonna, capsicum, chamomile, ferrum phosphoricum, kali muriaticum tablet

Homeopathic Ear Ache Formula by

Drug Labeling and Warnings

Homeopathic Ear Ache Formula by is a Homeopathic medication manufactured, distributed, or labeled by Indiana Botanic Gardens, ASI Marketing Group. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

I n g r e d i e n t s :

Aconite.............................. 30C HPUS
Deadly nightshade..........................................30C HPUS
Cayenne pepper......................... .................30C HPUS
Chamomile.........................................30C HPUS

Phosphate of iron..........................30C HPUS

Potassium chloride...................................30C HPUS

The letters “HPUS” indicate that the components in
this product are officially monographed in the
Homeopathic Pharmacopoeia of the United States.

PURPOSE

For the relief of ear pain due to soreness and swelling

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF
REACH OF CHILDREN.

INDICATIONS & USAGE

For the relief of ear pain due to soreness and swelling

WARNINGS

Warning: If you are taking any medications or
are pregnant or breast feeding do not use prior to
consulting a physician.

DOSAGE & ADMINISTRATION

Suggested Use: Adults and children over 12
years, take 2 tablets, dissolve under tongue or
chew 3 times daily or as directed by a health care professional.  If
condition worsens after 2 days and is accompanied by a high fever consult your
health professional.

INACTIVE INGREDIENT

Inactive Ingredients: Dextrose, Magnesium
Stearate, Silica.

PRINCIPAL DISPLAY PANEL

NDC# 1057804890

Homeopathic Ear Ache Formula

For the relief of ear pain due to soreness and swelling

300 mg.
90 Tablets

USER SAFETY WARNINGS

For your protection, this container has an outer
safety seal. (Do not accept if missing or broken.)
Best if used by date on bottle. Store in a dry cool place.
Any Questions? 1-800-644-8327
website: www.botanicchoice.com

SPL UNCLASSIFIED SECTION

FDA Establishment #: 1811575

Distributed by: Indiana Botanic Gardens, Inc.
3401 W. 37th Ave. Hobart, IN 46342

INGREDIENTS AND APPEARANCE

HOMEOPATHIC EAR ACHE FORMULA 
aconitum napellus, belladonna, capsicum, chamomile, ferrum phosphoricum, kali muriaticum tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10578-048
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	30 [hp_C]
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	30 [hp_C]
CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG)	CAPSICUM	30 [hp_C]
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X)	CHAMOMILE	30 [hp_C]
FERRUM PHOSPHORICUM (UNII: 91GQH8I5F7) (FERRUM PHOSPHORICUM - UNII:91GQH8I5F7)	FERRUM PHOSPHORICUM	30 [hp_C]
POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152)	POTASSIUM CHLORIDE	30 [hp_C]

Inactive Ingredients
Ingredient Name	Strength
DEXTROSE (UNII: IY9XDZ35W2)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	3mm
Flavor		Imprint Code	H;367
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10578-048-90	90 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		04/01/2009

Labeler - Indiana Botanic Gardens (005421771)

Registrant - Indiana Botanic Gardens (005421771)

Establishment
Name	Address	ID/FEI	Business Operations
Indiana Botanic Gardens		005421771	label

Establishment
Name	Address	ID/FEI	Business Operations
ASI Marketing Group		964366611	manufacture