CHILDRENS EARACHE RELIEF- arsenic trioxide - matricaria recutita - aconitum napellus - pulsatilla vulgaris - mercurius solubilis - silicon dioxide - tablet, chewable

Childrens Earache RELIEF by

Drug Labeling and Warnings

Childrens Earache RELIEF by is a Homeopathic medication manufactured, distributed, or labeled by Homeostasis Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

• Active Ingredients: Purpose
• Aconitum napallus 6C, HPUS: Relieves sudden onset of ear pain
• Arsenicum album 6C, HPUS: Relieves runny nose & restlessness
• Chamomilla 6C, HPUS: Relieves irritability and pain
• Mercurius solubilis 6C, HPUS: Eliminates discharge from ears
• Pulsatilla 6C, HPUS: Relieves ear pain and weepy mood
• Silicea 6C, HPUS: Relieves ear pain

"HPUS" indicates that the ingredient is officially included in the Homeopathic Pharmacopeia of the United States and the manufacturer has followed all guidelines set forth.

Statement of Identity: Relief of ear pain in children.

PURPOSE

Uses

For the relief of acute inflammation of the ear, pain, high fever and discharge from the ears.

Safe for children 6 months and older (if younger than 6 months consult your doctor first).

Warnings

• Do not use if outer package seal is broken.
• Stop use and consult a doctor if symptoms do not improve within 3 days, worsen or are accompanied by a persistent fever over 101˚F.

PREGNANCY OR BREAST FEEDING

KEEP OUT OF REACH OF CHILDREN

• Keep out of reach of children.

Directions

Give child one tablet and allow to chew or dissolve in the mouth. If you prefer, tablets may be dissolved in a teaspoon of water and then given to the child.

Repeat every 4 hours as needed.

Other information

• Safe to take with all other medications.
• Store at 68-77°F (20-25°C) and keep out of direct sunlight.
• Avoid humid or damp storage conditions. Close well when not in use.

Inactive Ingredients

Lactose, magnesium stearate (vegetable source).

DO NOT USE

Questions? Call toll free or email us at:

1-888-60-B-WELL (1-888-602-9355)

info@homeostasislabs.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CHILDRENS EARACHE RELIEF 
arsenic trioxide - matricaria recutita - aconitum napellus - pulsatilla vulgaris - mercurius solubilis - silicon dioxide - tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47242-0221
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	6 [hp_C]
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	6 [hp_C]
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	6 [hp_C]
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	6 [hp_C]
MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIC CATION - UNII:ED30FJ8Y42)	MERCURIUS SOLUBILIS	6 [hp_C]
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (COLLOIDAL SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	6 [hp_C]

Inactive Ingredients
Ingredient Name	Strength
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND (Heart)	Size	5mm
Flavor		Imprint Code	H
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47242-0221-1	1 in 1 PACKAGE
1		50 in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/01/2009

Labeler - Homeostasis Laboratories, Inc. (010569196)