Earache Relief

Manufacturer
The Magni Company | Apotheca Company
Effective date
2024-11-05
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:28:48

Label at a glance#

ProductEarache Relief
Active ingredientATROPA BELLADONNA, OYSTER SHELL CALCIUM CARBONATE, CRUDE, MATRICARIA CHAMOMILLA WHOLE, CALCIUM SULFIDE, POTASSIUM DICHROMATE, LYCOPODIUM CLAVATUM SPORE, PLANTAGO MAJOR WHOLE, PULSATILLA VULGARIS WHOLE
Label structure10 sections

Indications and uses

For temporary relief of earache symptoms, such as pain, pressure, congestion, itching, sleeplessness, and headaches, after diagnosis by a physician.

Dosage and administration

Adults and children 12 years and above:  dissolve 1-2 tablets under tongue, 2 to 3 times daily or as directed by a physician. Children under 12 years, consult a physician.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Belladonna 12X, Calcarea Carbonica 12X, Chamomilla 12X, Hepar Sulphuris Calcareum 12X, Kali Bichromicum 12X, Lycopodium Clavatum 12X, Plantago Major 12X, Pulsatilla (Vulgaris) 12X.

USES:

OTC - PURPOSE SECTION

For temporary relief of earache symptoms, such as pain, pressure, congestion, itching, sleeplessness, and headaches, after diagnosis by a physician.

WARNINGS:

WARNINGS SECTION

• If pregnant or breastfeeding, ask a health professional before use.

• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

• Stop use and ask a doctor if you experience worsening symptoms or if symptoms last longer than 7 days.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

OTHER INFORMATION:

OTHER SAFETY INFORMATION

• Store tightly closed in a cool, dry place (59° - 86°F)

• Tamper sealed: Sealed for your protection. Do not use if seal is broken or missing

• The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United
   States

• These statements are supported by the traditional homeopathic principles

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years and above:  dissolve 1-2 tablets under tongue, 2 to 3 times daily or as directed by a physician.

Children under 12 years, consult a physician.

INDICATIONS:

INDICATIONS & USAGE SECTION

For temporary relief of earache symptoms, such as pain, pressure, congestion, itching, sleeplessness, and headaches, after diagnosis by a physician.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Lactose, Magnesium Stearate, Microcrystalline Cellulose

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. by: The Magni Group, Inc. McKinney, TX 75071 USA

www.magnilife.com                               1-800-645-9199

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAGNILIFE Homeopathic

NDC 43689-0020-1

EARACHE RELIEF

Targets ear pain
for fast relief

Soothes ear pain and
discomfort due to:
√ Allergy
√ Cold & Flu
√ Congestion
√Swimmer's Ear

90 Dissolving Tablets

Earache Relief lblEarache Relief lbl

Earache Relief ctnEarache Relief ctn

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43689-0020-22024-11-05C16284748780-1ba0f9c33-365a-a910-e053-dadaa90a0b85Drug Facts:
43689-0020-22024-01-30C16284748780-1ba0f9c33-365a-a910-e053-dadaa90a0b85Drug Facts:
43689-0020-22022-01-10C16284748780-1ba0f9c33-365a-a910-e053-dadaa90a0b85Drug Facts:
43689-0020-22021-01-29C16284748780-1ba0f9c33-365a-a910-e053-dadaa90a0b85Drug Facts:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43689-0020-1Earache Relief90 in 1 BOTTLETABLET904
43689-0020-2Earache Relief1 in 1 PACKAGETABLET14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43689-0020EARACHE RELIEF (BELLADONNA, CALCAREA CARBONICA, CHAMOMILLA, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, PLANTAGO MAJOR, PULSATILLA (VULGARIS)) TABLET [THE MAGNI COMPANY]4Current NDC, Legacy NDC, 2 package rows20241107_3f62001a-27b5-43cb-8006-110943facf87.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43689-002043689-0020-1, 43689-0020-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Earache ReliefBELLADONNA, CALCAREA CARBONICA, CHAMOMILLA, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, PLANTAGO MAJOR, PULSATILLA (VULGARIS)The Magni Company3f62001a-27b5-43cb-8006-110943facf872024-11-05WarningsExact identifier
ndc (package): 43689-0020-2
ndc (package): 43689-0020-1
ndc (product): 43689-0020
ndc11 (package): 43689002002
ndc11 (package): 43689002001
spl id: 32934d7c-c3dc-4bfc-8b8c-ffbbc39768de
spl set id: 3f62001a-27b5-43cb-8006-110943facf87

Reported adverse events (FAERS/openFDA)#

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