Ear Ringing

Manufacturer
Newton Laboratories, Inc.
Effective date
2025-02-06
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:41:30

Label at a glance#

ProductEar Ringing
Active ingredientACONITUM NAPELLUS, BARIUM CARBONATE, BARIUM CHLORIDE DIHYDRATE, CAPSICUM, CAUSTICUM, DYSPHANIA AMBROSIOIDES, QUININE SULFATE, CINCHONA OFFICINALIS BARK, NITROGLYCERIN, GRAPHITE, GOLDENSEAL, POTASSIUM DICHROMATE, POTASSIUM CHLORIDE, LYCOPODIUM CLAVATUM SPORE, PHOSPHORUS, PULSATILLA VULGARIS, SALICYLIC ACID, TOBACCO LEAF, ALLYLTHIOUREA, VIOLA ODORATA
Label structure10 sections

Label contents#

Full prescribing information#

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) one to four times a day 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. 10x, Baryta carb. 10x, Baryta mur. 10x, Capsicum 10x, Causticum 10x, Chenopodium anthelminticum 10x, Chininum sulphuricum 10x, Cinchona 10x, Glonoinum 10x, Graphites 10x, Hydrastis 10x, Kali bic. 10x, Kali mur.10x, Lycopodium 10x, Phosphorus 10x, Pulsatilla 10x, Salicylicum ac.10x, Tabacum 10x, Thiosinaminum 10x, Viola odorata 10x.

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%

QUESTIONS SECTION

OTC - QUESTIONS SECTION

newtonlabs.net -Questions? 800.448.7256

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

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.

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.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2426EAR RINGING (ACONITUM NAP., BARYTA CARB., BARYTA MUR., CAPSICUM, CAUSTICUM, CHENOPODIUM ANTHELMINTICUM, CHININUM SULPHURICUM, CINCHONA, GLONOINUM, GRAPHITES, HYDRASTIS, KALI BIC., KALI MUR., LYCOPODIUM, PHOSPHORUS, PULSATILLA, SALICYLICUM AC., TABACUM, THIOSINAMINUM, VIOLA ODORATA) LIQUID [NEWTON LABORATORIES, INC.]4Legacy NDC20250209_93024322-52a8-e31a-e053-2a95a90af95e.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-242655714-2426-1, 55714-2426-2, 55714-2426-0

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3b17cc24-73ea-e7e0-e063-6294a90a635693024322-52a8-e31a-e053-2a95a90af95e2025-07-29WarningsExact identifier
spl set id: 93024322-52a8-e31a-e053-2a95a90af95e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.