Wellness Earache

Manufacturer
Source Naturals, Inc. | Apotheca Company
Effective date
2022-11-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:47:53

Label at a glance#

ProductWellness Earache
Active ingredientCAPSICUM, SILICON DIOXIDE, VERBASCUM THAPSUS, FERRUM PHOSPHORICUM, POTASSIUM CHLORIDE, ACONITUM NAPELLUS, OYSTER SHELL CALCIUM CARBONATE, CRUDE, PULSATILLA PRATENSIS
Label structure9 sections

Dosage and administration

Chew 1 tablet slightly and let it dissolve in the mouth. For infants, crush a tablet between two spoons, add water or juice if desired, and place in mouth. Repeat every 2 to 4 hours as needed, for up to 48 hours. For optimal results take 3-4 doses per day. One or two doses per day may be taken for up to 4 weeks if symptoms recur or do not resolve completely. Give Wellness EarAche to children or infants over 6 mont...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Capsicum Annuum 6X, Silicea 6X, Verbascum Thapsus 6X, Ferrum Phosphoricum 12X, Kali Muriaticum 12X, Aconitum Napellus 30X, Calcarea Carbonica 30X, Pulsatilla (Pratensis) 30X.

INDICATIONS:

OTC - PURPOSE SECTION

For the temporary relief of ear pain, blockage, ear inflammation, irritability and fever associated with earaches.

Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

STORE IN A COOL, DRY PLACE.

WARNINGS:

WARNINGS SECTION

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

A high fever may be the sign of a serious health condition. If fever or ear pain persist for more than 2 days or new symptoms occur, consult a physician.

As with any medicine, if you are pregnant, may become pregnant, or breastfeeding, seek the advice of a physician before using this product.

Keep this and all medicines out of the reach of children.

Tamper Evident: Do not use if foil blister backing is broken. Foil backing is printed with product name and lot number.

Contains Milk.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Chew 1 tablet slightly and let it dissolve in the mouth. For infants, crush a tablet between two spoons, add water or juice if desired, and place in mouth. Repeat every 2 to 4 hours as needed, for up to 48 hours. For optimal results take 3-4 doses per day.

One or two doses per day may be taken for up to 4 weeks if symptoms recur or do not resolve completely.

Give Wellness EarAche to children or infants over 6 months of age. This product is not recommended for use by infants under 6 months of age without the advice of your physician.

For Best Results: Keep mouth free of food and strong tastes (such as toothpaste, mouthwash and tobacco) for 15 minutes before and after taking this medicine. These substances may interfere with absorption.

INDICATIONS:

INDICATIONS & USAGE SECTION

For the temporary relief of ear pain, blockage, ear inflammation, irritability and fever associated with earaches.

Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

STORE IN A COOL, DRY PLACE.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Lactose, Magnesium Stearate.

QUESTIONS:

OTC - QUESTIONS SECTION

Source Naturals, Inc.
P.O. Box 2118
Santa Cruz, CA. USA 95062
www.sourcenaturals.com

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SOURCE NATURALS
with
PainSoothe
Homeopathic
Children's
Formula
Wellness
EarAche
Pain • Blockage • Inflammation • Irritability • Fever
48 HOMEOPATHIC TABLETS

Wellness EarAche ctn frontWellness EarAche ctn front

Wellness EarAche ctn backWellness EarAche ctn back

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64471-126-482021-03-25C16284748780-19d75b9d0-51a0-f424-e053-dadaa90a57ceDrug Facts:
64471-126-482020-01-31C16284748780-19d75b9d0-51a0-f424-e053-dadaa90a57ceDrug Facts:

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64471-12664471-126-48

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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
eb9b45f1-8847-4563-a578-ca14e985441df6876cd5-4353-48bd-b1bf-610c928bcb1b2022-11-16WarningsExact identifier
spl id: eb9b45f1-8847-4563-a578-ca14e985441d
spl set id: f6876cd5-4353-48bd-b1bf-610c928bcb1b

Reported adverse events (FAERS/openFDA)#

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