Tinnitus 4857l

Tinnitus 4857l
SPL v1
SPL
SPL Set ID 10462aaa-96d4-4ba3-e063-6294a90a7915
Route
ORAL
Published
Effective Date 2024-01-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aconitum Napellus (20 [hp_X]) Barium Cation Capsicum Causticum Dysphania Ambrosioides Quinine Cinchona Officinalis Bark Nitroglycerin Graphite Goldenseal Dichromate Ion Potassium Cation Lycopodium Clavatum Spore Anemone Pulsatilla Salicylic Acid Tobacco Leaf Allylthiourea Viola Odorata Phosphorus
Inactive Ingredients
Alcohol Water

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 6 to 11, give 3 drops) as needed or as directed by a health professional.

Otc Active Ingredient Section

Equal parts of Hydrastis canadensis 11x, Aconitum napellus 20x, Baryta carbonica 20x, Baryta muriatica 20x, Capsicum annuum 20x, Causticum 20x, Chenopodium anthelminticum 20x, Chininum sulphuricum 20x, Cinchona officinalis 20x, Glonoinum 20x, Graphites 20x, Hydrastis canadensis 20x, Kali bichromicum 20x, Kali muriaticum 20x, Lycopodium clavatum 20x, Phosphorus 20x, Pulsatilla 20x, Salicylicum acidum 20x, Tabacum 20x, Thiosinaminum 20x, Viola odorata 20x.

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 6 to 11, give 3 drops) as needed or as directed by a health professional.

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Equal parts of Hydrastis canadensis 11x, Aconitum napellus 20x, Baryta carbonica 20x, Baryta muriatica 20x, Capsicum annuum 20x, Causticum 20x, Chenopodium anthelminticum 20x, Chininum sulphuricum 20x, Cinchona officinalis 20x, Glonoinum 20x, Graphites 20x, Hydrastis canadensis 20x, Kali bichromicum 20x, Kali muriaticum 20x, Lycopodium clavatum 20x, Phosphorus 20x, Pulsatilla 20x, Salicylicum acidum 20x, Tabacum 20x, Thiosinaminum 20x, Viola odorata 20x.

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)