Children's Ear Relief ™

Children's Ear Relief ™
SPL v1
SPL
SPL Set ID e91d66b9-fe7e-4542-88a6-59c120defde9
Route
ORAL
Published
Effective Date 2014-03-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aconitum Napellus (10 [hp_X]) Onion Apis Mellifera Atropa Belladonna Oyster Shell Calcium Carbonate, Crude Capsicum Causticum Matricaria Recutita Solanum Dulcamara Top Ferrosoferric Phosphate Calcium Sulfide Potassium Cation Calomel Mercurius Solubilis Plantago Major Colloidal Silicon Dioxide
Inactive Ingredients
Water Citric Acid Monohydrate Potassium Sorbate

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2014-03-31
Description

Drug Facts ____________________________________________________________________________________________________________________ HPUS active ingredients: Aconitum napellus, Allium cepa, Apis mellifica, Belladonna, Calcarea carbonica, Capsicum annuum, Causticum, Chamomilla, Dulcamara, Ferrum phosphoricum, Hepar sulphuris calcareum, Kali muriaticum, Mercurius dulcis, Mercurius solubilis, Plantago major, Silicea. Equal volumes of each ingredient in 10X, 30X, 100X, 1M, LM1, LM2, LM3 potencies.

Medication Information

Warnings and Precautions

Warnings

  • Stop use and ask your doctor if symptoms persist or worsen.
  • If pregnant or breast-feeding, take only on advice of a healthcare professional.

Indications and Usage

Uses  NOTE: Do not use in ear. Oral spray only. For temporary relief of symptoms: clogged sensation, noises in ear, accumulation of ear wax.

Dosage and Administration

Directions

  • Initially, depress pump until primed.
  • Spray one dose directly into mouth.
  • Adults 12 and up 3 sprays 3 times per day.
  • Children 2-12- 2 sprays 3 times per day.
  • Children 2 mo.-2yr.- 1 spray 3 times per day.
Description

Drug Facts ____________________________________________________________________________________________________________________ HPUS active ingredients: Aconitum napellus, Allium cepa, Apis mellifica, Belladonna, Calcarea carbonica, Capsicum annuum, Causticum, Chamomilla, Dulcamara, Ferrum phosphoricum, Hepar sulphuris calcareum, Kali muriaticum, Mercurius dulcis, Mercurius solubilis, Plantago major, Silicea. Equal volumes of each ingredient in 10X, 30X, 100X, 1M, LM1, LM2, LM3 potencies.

Section 50565-1
  • Keep out of reach of children.
Section 51727-6

Inactive ingredients: Bio-Energetically Enhanced pure water, citric acid, potassium sorbate.

Section 51945-4

Section 55105-1

Uses NOTE: Do not use in ear. Oral spray only. For temporary relief of symptoms:

  • clogged sensation
  • noises in ear
  • accumulation of ear wax
Section 55106-9

Drug Facts

____________________________________________________________________________________________________________________

HPUS active ingredients: Aconitum napellus, Allium cepa, Apis mellifica, Belladonna, Calcarea carbonica, Capsicum annuum, Causticum, Chamomilla, Dulcamara, Ferrum phosphoricum, Hepar sulphuris calcareum, Kali muriaticum, Mercurius dulcis, Mercurius solubilis, Plantago major, Silicea. Equal volumes of each ingredient in 10X, 30X, 100X, 1M, LM1, LM2, LM3 potencies.

Section 60561-8

Tamper resistant for your protection. Use only if safety seal is intact. This product has not been independently tested.

Structured Label Content

Indications and Usage (34067-9)

Uses  NOTE: Do not use in ear. Oral spray only. For temporary relief of symptoms: clogged sensation, noises in ear, accumulation of ear wax.

Dosage and Administration (34068-7)

Directions

  • Initially, depress pump until primed.
  • Spray one dose directly into mouth.
  • Adults 12 and up 3 sprays 3 times per day.
  • Children 2-12- 2 sprays 3 times per day.
  • Children 2 mo.-2yr.- 1 spray 3 times per day.
Warnings and Precautions (34071-1)

Warnings

  • Stop use and ask your doctor if symptoms persist or worsen.
  • If pregnant or breast-feeding, take only on advice of a healthcare professional.

Section 50565-1 (50565-1)
  • Keep out of reach of children.
Section 51727-6 (51727-6)

Inactive ingredients: Bio-Energetically Enhanced pure water, citric acid, potassium sorbate.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Uses NOTE: Do not use in ear. Oral spray only. For temporary relief of symptoms:

  • clogged sensation
  • noises in ear
  • accumulation of ear wax
Section 55106-9 (55106-9)

Drug Facts

____________________________________________________________________________________________________________________

HPUS active ingredients: Aconitum napellus, Allium cepa, Apis mellifica, Belladonna, Calcarea carbonica, Capsicum annuum, Causticum, Chamomilla, Dulcamara, Ferrum phosphoricum, Hepar sulphuris calcareum, Kali muriaticum, Mercurius dulcis, Mercurius solubilis, Plantago major, Silicea. Equal volumes of each ingredient in 10X, 30X, 100X, 1M, LM1, LM2, LM3 potencies.

Section 60561-8 (60561-8)

Tamper resistant for your protection. Use only if safety seal is intact. This product has not been independently tested.

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:09:17.582523 · Updated: 2026-03-14T23:14:29.546572