Earca 1537l

Earca 1537l
SPL v1
SPL
SPL Set ID da717cf0-54af-c4e2-e053-2995a90ac97c
Route
ORAL
Published
Effective Date 2022-03-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Influenza B Virus (30 [hp_X]) Echinacea, Unspecified (6 [hp_X]) Ferrosoferric Phosphate (15 [hp_X]) Apis Mellifera (16 [hp_X]) Arsenic Cation (3+) Atropa Belladonna Bryonia Alba Root Capsicum Causticum Cinchona Officinalis Bark Conium Maculatum Flowering Top Solanum Dulcamara Top Potassium Cation Lycopodium Clavatum Spore Mercury Daphne Mezereum Bark Phosphorus Silicon Dioxide Plantago Major Anemone Pulsatilla Tellurium Verbascum Thapsus Influenza A Virus Calcium Sulfide Goldenseal
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2022-03-07

Description

Formulated for associated symptoms such as redness, pain, congestion, hearing difficulty, inflammation and irritability.

Indications and Usage

Formulated for associated symptoms such as redness, pain, congestion, hearing difficulty, inflammation and irritability.

Purpose

Formulated for associated symptoms such as redness, pain, congestion, hearing difficulty, inflammation and irritability.


Medication Information

Indications and Usage

Formulated for associated symptoms such as redness, pain, congestion, hearing difficulty, inflammation and irritability.

Purpose

Formulated for associated symptoms such as redness, pain, congestion, hearing difficulty, inflammation and irritability.

Description

Formulated for associated symptoms such as redness, pain, congestion, hearing difficulty, inflammation and irritability.

Package Label

Warnings Section

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

Questions Section

newtonlabs.net – Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

Otc Purpose Section

Formulated for associated symptoms such as redness, pain, congestion, hearing difficulty, inflammation and irritability.

Inactive Ingredient Section

USP Purified water; USP Gluten-free, non-GMO, organic cane alcohol 20%

Indications and Usage Section

Formulated for associated symptoms such as redness, pain, congestion, hearing difficulty, inflammation and irritability.

Dosage & Administration Section

Directions: Children, ages 0 to 11, give 3 drops by mouth (ages 12 and up, give 6 drops) one to four times daily or a directed by a health professional. Sensitive person begin with 1 drop and gradually increase to full dose.

Otc Active Ingredient Section

Equal parts of Echinacea 6x, Hydrastis canadensis 6x, Apis mellifica 15x, Arsenicum album 15x, Belladonna 15x, Bryonia 15x, Capsicum annuum 15x, Causticum 15x, Cinchona officinalis 15x, Conium maculatum 15x, Dulcamara 15x, Ferrum phosphoricum 15x, Hepar sulphuris calcareum 15x, Kali sulphuricum 15x, Lycopodium clavatum 15x, Mercurius vivus 15x, Mezereum 15x, Phosphorus 15x, Plantago major 15x, Pulsatilla 15x, Silicea 15x, Tellurium metallicum 16x, Verbascum thapsus 15x, Influenzinum 30x.

Otc Pregnancy Or Breast Feeding Section

If pregnant or breast-feeding, ask a doctor before use.

Otc Keep Out of Reach of Children Section

WARNINGS: Keep out of reach of children.


Structured Label Content

Package Label (PACKAGE LABEL)

Warnings Section (WARNINGS SECTION)

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

Questions Section (QUESTIONS SECTION)

newtonlabs.net – Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

Otc Purpose Section (OTC - PURPOSE SECTION)

Formulated for associated symptoms such as redness, pain, congestion, hearing difficulty, inflammation and irritability.

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

USP Purified water; USP Gluten-free, non-GMO, organic cane alcohol 20%

Indications and Usage Section (INDICATIONS AND USAGE SECTION)

Formulated for associated symptoms such as redness, pain, congestion, hearing difficulty, inflammation and irritability.

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Directions: Children, ages 0 to 11, give 3 drops by mouth (ages 12 and up, give 6 drops) one to four times daily or a directed by a health professional. Sensitive person begin with 1 drop and gradually increase to full dose.

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Equal parts of Echinacea 6x, Hydrastis canadensis 6x, Apis mellifica 15x, Arsenicum album 15x, Belladonna 15x, Bryonia 15x, Capsicum annuum 15x, Causticum 15x, Cinchona officinalis 15x, Conium maculatum 15x, Dulcamara 15x, Ferrum phosphoricum 15x, Hepar sulphuris calcareum 15x, Kali sulphuricum 15x, Lycopodium clavatum 15x, Mercurius vivus 15x, Mezereum 15x, Phosphorus 15x, Plantago major 15x, Pulsatilla 15x, Silicea 15x, Tellurium metallicum 16x, Verbascum thapsus 15x, Influenzinum 30x.

Otc Pregnancy Or Breast Feeding Section (OTC - PREGNANCY OR BREAST FEEDING SECTION)

If pregnant or breast-feeding, ask a doctor before use.

Otc Keep Out of Reach of Children Section (OTC - KEEP OUT OF REACH OF CHILDREN SECTION)

WARNINGS: Keep out of reach of children.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)