Childrens Earache RELIEF

Manufacturer: Homeostasis Laboratories, Inc.
Effective date: 2012-11-14
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 02:04:10

Label at a glance#

ProductChildrens Earache RELIEF

Active ingredientARSENIC TRIOXIDE, MATRICARIA RECUTITA, ACONITUM NAPELLUS, PULSATILLA VULGARIS, MERCURIUS SOLUBILIS, SILICON DIOXIDE

Label structure9 sections

Indications and 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).

Dosage and administration

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.

Contacts and useful links#

PhoneLabel contact1-888-602-9355

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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.

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

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

INACTIVE INGREDIENT SECTION

Lactose, magnesium stearate (vegetable source).

Questions? Call toll free or email us at:

OTC - QUESTIONS SECTION

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

info@homeostasislabs.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139	Product name	3	20240506
e5a77e9c-c528-733a-173d-914a234c024b	Product name	5	20240506

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
47242-0221-1	2020-01-31	C162847	48780-1	9d75b9d0-0f3d-f424-e053-dadaa90a57ce	Children's Earache RELIEF

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
47242-0221-1	Childrens Earache RELIEF	1 in 1 PACKAGE	TABLET, CHEWABLE	1		1
47242-0221-1	Childrens Earache RELIEF	50 in 1 TUBE	TABLET, CHEWABLE	50		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
47242-0221	CHILDRENS EARACHE RELIEF (ARSENIC TRIOXIDE - MATRICARIA RECUTITA - ACONITUM NAPELLUS - PULSATILLA VULGARIS - MERCURIUS SOLUBILIS - SILICON DIOXIDE -) TABLET, CHEWABLE [HOMEOSTASIS LABORATORIES, INC.]	1	Legacy NDC, 2 package rows	20121116_93208ee8-1a3b-48de-bde5-d5c2fdb89ab1.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ACONITUM NAPELLUS	ACTIVE INGREDIENT	U0NQ8555JD	1
ARSENIC TRIOXIDE	ACTIVE INGREDIENT	S7V92P67HO	1
MATRICARIA RECUTITA	ACTIVE INGREDIENT	G0R4UBI2ZZ	1
MERCURIUS SOLUBILIS	ACTIVE INGREDIENT	324Y4038G2	1
PULSATILLA VULGARIS	ACTIVE INGREDIENT	I76KB35JEV	1
SILICON DIOXIDE	ACTIVE INGREDIENT	ETJ7Z6XBU4	1
ACONITUM NAPELLUS	ACTIVE MOIETY	U0NQ8555JD	1
ARSENIC CATION (3+)	ACTIVE MOIETY	C96613F5AV	1
COLLOIDAL SILICON DIOXIDE	ACTIVE MOIETY	ETJ7Z6XBU4	1
MATRICARIA RECUTITA	ACTIVE MOIETY	G0R4UBI2ZZ	1
MERCURIC CATION	ACTIVE MOIETY	ED30FJ8Y42	1
PULSATILLA VULGARIS	ACTIVE MOIETY	I76KB35JEV	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

Childrens Earache RELIEF
ARSENIC TRIOXIDE - MATRICARIA RECUTITA - ACONITUM NAPELLUS - PULSATILLA VULGARIS - MERCURIUS SOLUBILIS - SILICON DIOXIDE -
ARSENIC TRIOXIDE
ARSENIC CATION (3+)
MATRICARIA RECUTITA
ACONITUM NAPELLUS
PULSATILLA VULGARIS
MERCURIUS SOLUBILIS
MERCURIC CATION
SILICON DIOXIDE
COLLOIDAL SILICON DIOXIDE
LACTOSE
MAGNESIUM STEARATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
47242-0221	47242-0221-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ARSENIC TRIOXIDE	S7V92P67HO	ACTIB
MATRICARIA RECUTITA	G0R4UBI2ZZ	ACTIB
ACONITUM NAPELLUS	U0NQ8555JD	ACTIB
PULSATILLA VULGARIS	I76KB35JEV	ACTIB
MERCURIUS SOLUBILIS	324Y4038G2	ACTIB
SILICON DIOXIDE	ETJ7Z6XBU4	ACTIB
LACTOSE	J2B2A4N98G	IACT
MAGNESIUM STEARATE	70097M6I30	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 75 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SYSTEM / INTRAVITREAL	0.02 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FOR SUSPENSION / ORAL		131 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	INSERT / VAGINAL		69 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	IMPLANT / INTRAVITREAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, EXTENDED RELEASE / ORAL	400 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	LOZENGE / ORAL		420 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		620 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE / ORAL	530 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	POWDER / RESPIRATORY (INHALATION)	90 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / ORAL	2500 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / BUCCAL	296.7 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SUSPENSION / ORAL		64 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / RECTAL	20 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / TOPICAL		104 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		53 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CREAM / TOPICAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / RESPIRATORY (INHALATION)	0.13 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	POWDER / VAGINAL	430 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / BUCCAL	17.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	SOLUTION / RECTAL	8 %w/v		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CONCENTRATE / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	GRANULE, FOR SUSPENSION / ORAL		14 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, CHEWABLE / ORAL		1412 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, EXTENDED RELEASE / ORAL		173 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, EFFERVESCENT / ORAL	96.5 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	FILM, EXTENDED RELEASE / TRANSDERMAL	675 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	DROPS / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	133 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, EXTENDED RELEASE / ORAL	120 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CREAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, ORALLY DISINTEGRATING / ORAL		187 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		9 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	SOLUTION / ORAL	1682 mg/15ml		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	INHALANT / ORAL	0.08 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	GRANULE, FOR SUSPENSION / ORAL	512.5 mg/5ml		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, COATED PELLETS / ORAL	135.2 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	RING / VAGINAL		2 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, SOLUTION / INTRAVENOUS	0.45 %w/v		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER, FOR SUSPENSION / ORAL		120 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	PELLET / ORAL		24 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY	193.8 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE / ORAL		127 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, COATED / ORAL	332.05 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	133 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TROCHE / ORAL		315 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SUSPENSION, EXTENDED RELEASE / ORAL		71 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, DELAYED RELEASE / ORAL		144 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, DELAYED RELEASE / ORAL	231.84 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / ORAL		25 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	LOZENGE / TRANSMUCOSAL		100 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION / INTRAMUSCULAR	203.5 mg		Exact identifier — unii candidate 36 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
6f1ad4d3-83b8-4e30-90a5-b6390bc8ac9d			93208ee8-1a3b-48de-bde5-d5c2fdb89ab1	2012-11-14	Warnings	Exact identifier spl id: 6f1ad4d3-83b8-4e30-90a5-b6390bc8ac9d spl set id: 93208ee8-1a3b-48de-bde5-d5c2fdb89ab1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.