Pediatric Earache Remedy

Manufacturer
Vitality Works, Inc | Vitality Works, Inc.
Effective date
2025-12-17
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 02:36:09

Key Label Information#

Active Ingredients And Purpose

Pediatric Earache Remedy

Aconitum napellus 6X Belladonna 3X Chamonilla 6X Kali mur 3X Plantago major 3X Verbascum 6X

Pediatric Earache Remedy

Aconitum napellus - relieves earach, hot, painful, swollen ear. Belladonna - relieves otitis media, throbbing deep ear pain. Chamomilla - relieves earache, soreness, swelling, otalgia. Kali mur - relieves chronic catarrahal conditions of middle ear. Plantago major - relieves earache, neuralgic earache, otalgia Verbascum - Relieves catarrhs, otalgia with sense of obstruction.

Uses

Pediatric Earache Remedy

A homeopathic combination for the temporary relief of earaches, inflammation of external and internal ear. For the temporary relief of earaches from congestion or swelling of middle ear or eustacian tubes.

Warnings

Pediatric Earache Remedy

Keep this and all medicines out of reach of children. Before use with children under 3 years of age, or if you are pregnant or nursing, seek the advice of you health care professional. Avoid contact with eyes. If symptoms persist for more than 4 days, or if there is discharge from the ear or perforation, discontinue use and contact your health care professional. In case of accidental overdose, seek professional assistance or contact a poison control center immediately. All the ingredients are edible but they are not intended for internal use.

Directions And Dosage

Pediatric Earache Remedy

Warm up bottle by gently rolling it between your hands before use. Tilt head sideways and place 2 to 3 drops into ear. Tip of applicator should not enter ear canal. Repeat 2-3 times/day for up to 4 days, if needed, or as directed by your health care professional.

Other Label Information

Pediatric Earache Remedy

Grapefruit Seed Extract, Olive Leaf Extract, USP Purified Water

Pediatric Earache Remedy

Label Images#

Pediatric Earche Remedy Full Image 1
Pediatric Earche Remedy Full Image 1
pediatric Earache Remedy full image carton
pediatric Earache Remedy full image carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
95250459-30e4-45c1-b08a-993044f49109Product name220250805
d9771140-739b-484b-ae64-b79528ff1211Product name320250801
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
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cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
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9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
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7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64616-050-01Pediatric Earache Remedy15 mL in 1 BOTTLE, DROPPERLIQUID159
64616-050-02Pediatric Earache Remedy1 in 1 CARTONLIQUID19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACONITUM NAPELLUSACTIVE INGREDIENTU0NQ8555JD1
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0H1
MATRICARIA RECUTITAACTIVE INGREDIENTG0R4UBI2ZZ1
PLANTAGO MAJORACTIVE INGREDIENTW2469WNO6U1
POTASSIUM CHLORIDEACTIVE INGREDIENT660YQ98I101
VERBASCUM THAPSUSACTIVE INGREDIENTC9TD27U1721
ACONITUM NAPELLUSACTIVE MOIETYU0NQ8555JD1
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0H1
MATRICARIA RECUTITAACTIVE MOIETYG0R4UBI2ZZ1
PLANTAGO MAJORACTIVE MOIETYW2469WNO6U1
POTASSIUM CATIONACTIVE MOIETY295O53K1521
VERBASCUM THAPSUSACTIVE MOIETYC9TD27U1721
CITRUS PARADISI SEEDINACTIVE INGREDIENT12F08874Y71
OLEA EUROPAEA LEAFINACTIVE INGREDIENTMJ95C3OH471
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64616-05064616-050-01, 64616-050-02

Ingredients#

Complete SPL Sections#

Pediatric Earache Remedy

OTC - ACTIVE INGREDIENT SECTION

Aconitum napellus 6X Belladonna 3X Chamonilla 6X Kali mur 3X Plantago major 3X Verbascum 6X

Pediatric Earache Remedy

INACTIVE INGREDIENT SECTION

Grapefruit Seed Extract, Olive Leaf Extract, USP Purified Water

Pediatric Earache Remedy

WARNINGS SECTION

Keep this and all medicines out of reach of children. Before use with children under 3 years of age, or if you are pregnant or nursing, seek the advice of you health care professional. Avoid contact with eyes. If symptoms persist for more than 4 days, or if there is discharge from the ear or perforation, discontinue use and contact your health care professional. In case of accidental overdose, seek professional assistance or contact a poison control center immediately. All the ingredients are edible but they are not intended for internal use.

Pediatric Earache Remedy

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medicines out reach of children.

Pediatric Earache Remedy

INDICATIONS & USAGE SECTION

A homeopathic combination for the temporary relief of earaches, inflammation of external and internal ear. For the temporary relief of earaches from congestion or swelling of middle ear or eustacian tubes.

Pediatric Earache Remedy

DOSAGE & ADMINISTRATION SECTION

Warm up bottle by gently rolling it between your hands before use. Tilt head sideways and place 2 to 3 drops into ear. Tip of applicator should not enter ear canal. Repeat 2-3 times/day for up to 4 days, if needed, or as directed by your health care professional.

Pediatric Earache Remedy

OTC - PURPOSE SECTION

Aconitum napellus - relieves earach, hot, painful, swollen ear. Belladonna - relieves otitis media, throbbing deep ear pain. Chamomilla - relieves earache, soreness, swelling, otalgia. Kali mur - relieves chronic catarrahal conditions of middle ear. Plantago major - relieves earache, neuralgic earache, otalgia Verbascum - Relieves catarrhs, otalgia with sense of obstruction.

Pediatric Earache Remedy

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document#

Source XML