SPL v2
SPL
SPL Set ID ebf8c279-35a4-4daf-bc27-b1fdbcd0a25c
Route
ORAL
Published
Effective Date 2018-03-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ferrosoferric Phosphate (30 [hp_X]) Capsicum Rancid Beef Arsenic Cation (3+)
Inactive Ingredients
Water Sorbitol Sodium Benzoate Potassium Sorbate Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2017-03-03

Description

Active ingredients HPUS : Ferrum phosphoricum 30X    (Ferrosoferic phosphate) Capsicum annuum 30X    (Cayenne pepper) Pyrogenium 30X    (Pyrogen) Arsenicum album 30X    (Arsenous oxide) The letters 'HPUS' indicate that the component in this product is officially monographed in the Homeopathic Pharmacopoeia of the United States)


Medication Information

Warnings and Precautions

Warnings

Stop use and ask a doctor in cases of high fever or if

symptoms worsen or persist for more than 2 days.

Indications and Usage

Uses

This oral homeopathic medicine is made from a combination

of ingredients traditionally used to help relieve* the sensa-

tion of fullness of the ear, sensitivity to water and drafts, and

the annoyance of water-clogged ears by helping clear water

trapped in the ear.

Dosage and Administration

Directions

Children under 6 months of age: Consult a licensed

healthcare practitioner before using this product

Children 6 months to 2 years old: 0.5 ml orally every 8 hours

or 3 times a day

Children 2 to 9 years old: 0.75 ml orally every 8 hours or 3

times a day

Description

Active ingredients HPUS : Ferrum phosphoricum 30X    (Ferrosoferic phosphate) Capsicum annuum 30X    (Cayenne pepper) Pyrogenium 30X    (Pyrogen) Arsenicum album 30X    (Arsenous oxide) The letters 'HPUS' indicate that the component in this product is officially monographed in the Homeopathic Pharmacopoeia of the United States)

Section 44425-7

Other information

•Store at room temperature

Do not use if bottle seal is

broken or missing.

Section 50565-1

Keep out of reach of children.

Section 51727-6

Inactive ingredients

Purified water, sorbitol, grape

and raspberry flavor, sodium

benzoate, potassium sorbate,

citric acid.

Section 55105-1

Purpose

Ferrum phosphoricum 30X ..............sensitivity to touch

(Ferrosoferic phosphate)

Capsicum annuum 30X ...................sensitivity to touch  fullness of the ear

(Cayenne pepper)

Pyrogenium 30X ............................coldness and chilliness,

(Pyrogen)

Arsenicum album 30X ....................burning sensation of the ear, night time calmative

(Arsenous oxide)

Section 55106-9

Active ingredients HPUS:

Ferrum phosphoricum 30X

   (Ferrosoferic phosphate)

Capsicum annuum 30X

   (Cayenne pepper)

Pyrogenium 30X

   (Pyrogen)

Arsenicum album 30X

   (Arsenous oxide)

The letters 'HPUS' indicate that the component in this product is officially

monographed in the Homeopathic Pharmacopoeia of the United States)

Kids Relief Ear Relief Oral Liquid


Structured Label Content

Indications and Usage (34067-9)

Uses

This oral homeopathic medicine is made from a combination

of ingredients traditionally used to help relieve* the sensa-

tion of fullness of the ear, sensitivity to water and drafts, and

the annoyance of water-clogged ears by helping clear water

trapped in the ear.

Dosage and Administration (34068-7)

Directions

Children under 6 months of age: Consult a licensed

healthcare practitioner before using this product

Children 6 months to 2 years old: 0.5 ml orally every 8 hours

or 3 times a day

Children 2 to 9 years old: 0.75 ml orally every 8 hours or 3

times a day

Warnings and Precautions (34071-1)

Warnings

Stop use and ask a doctor in cases of high fever or if

symptoms worsen or persist for more than 2 days.

Section 44425-7 (44425-7)

Other information

•Store at room temperature

Do not use if bottle seal is

broken or missing.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

Inactive ingredients

Purified water, sorbitol, grape

and raspberry flavor, sodium

benzoate, potassium sorbate,

citric acid.

Section 55105-1 (55105-1)

Purpose

Ferrum phosphoricum 30X ..............sensitivity to touch

(Ferrosoferic phosphate)

Capsicum annuum 30X ...................sensitivity to touch  fullness of the ear

(Cayenne pepper)

Pyrogenium 30X ............................coldness and chilliness,

(Pyrogen)

Arsenicum album 30X ....................burning sensation of the ear, night time calmative

(Arsenous oxide)

Section 55106-9 (55106-9)

Active ingredients HPUS:

Ferrum phosphoricum 30X

   (Ferrosoferic phosphate)

Capsicum annuum 30X

   (Cayenne pepper)

Pyrogenium 30X

   (Pyrogen)

Arsenicum album 30X

   (Arsenous oxide)

The letters 'HPUS' indicate that the component in this product is officially

monographed in the Homeopathic Pharmacopoeia of the United States)

Kids Relief Ear Relief Oral Liquid


Advanced Ingredient Data


Raw Label Data

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