Ear Ri-2588l

Ear Ri-2588l
SPL v1
SPL
SPL Set ID 1043debe-8787-a2f5-e063-6294a90a2a66
Route
ORAL
Published
Effective Date 2024-01-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aconitum Napellus (15 [hp_X]) Barium Cation Capsicum Causticum Dysphania Ambrosioides Quinine Cinchona Officinalis Bark Nitroglycerin Graphite Goldenseal Dichromate Ion Potassium Cation Lycopodium Clavatum Spore Phosphorus Pulsatilla Vulgaris Salicylic Acid Tobacco Leaf Allylthiourea Viola Odorata
Inactive Ingredients
Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2024-01-31

Description

Formulated for associated symptoms such as ringing, buzzing, echoing, pressure, pain, throbbing and sensitivity to noise.

Purpose

Formulated for associated symptoms such as ringing, buzzing, echoing, pressure, pain, throbbing and sensitivity to noise.


Medication Information

Purpose

Formulated for associated symptoms such as ringing, buzzing, echoing, pressure, pain, throbbing and sensitivity to noise.

Description

Formulated for associated symptoms such as ringing, buzzing, echoing, pressure, pain, throbbing and sensitivity to noise.

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 ringing, buzzing, echoing, pressure, pain, throbbing and sensitivity to noise.

Inactive Ingredient Section

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%

Indications & Usage Section

Formulated for associated symptoms such as ringing, buzzing, echoing, pressure, pain, throbbing and sensitivity to noise.

Dosage & Administration Section

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

Otc Active Ingredient Section

Equal parats of Hydrastis 6x, Aconitum nap. 15x, Baryta carb. 15x, Baryta mur. 15x, Capsicum 15x, Causticum 15x, Chenopodium anthelminticum 15x, Chininum sulphuricum 15x, Cinchona 15x, Glonoinum 15x, Graphites 15x, Hydrastis 15x, Kali bic. 15x, Kali mur.15x, Lycopodium 15x, Phosphorus 15x, Pulsatilla 15x, Salicylicum ac.15x, Tabacum 15x, Thiosinaminum 15x, Viola odorata 15x.

Otc Pregnancy Or Breast Feeding Section

WARNINGS: 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 ringing, buzzing, echoing, pressure, pain, throbbing and sensitivity to noise.

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%

Indications & Usage Section (INDICATIONS & USAGE SECTION)

Formulated for associated symptoms such as ringing, buzzing, echoing, pressure, pain, throbbing and sensitivity to noise.

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Equal parats of Hydrastis 6x, Aconitum nap. 15x, Baryta carb. 15x, Baryta mur. 15x, Capsicum 15x, Causticum 15x, Chenopodium anthelminticum 15x, Chininum sulphuricum 15x, Cinchona 15x, Glonoinum 15x, Graphites 15x, Hydrastis 15x, Kali bic. 15x, Kali mur.15x, Lycopodium 15x, Phosphorus 15x, Pulsatilla 15x, Salicylicum ac.15x, Tabacum 15x, Thiosinaminum 15x, Viola odorata 15x.

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

WARNINGS: 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)