FDA.reportPublic FDA data

SEVENE USA - Throat Ease - Sore throat

Manufacturer
SEVENE USA | SEVENE
Effective date
2026-08-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-08-21 02:00:52

Label at a glance#

ProductThroat Ease Sore throat
Active ingredientATROPA BELLADONNA WHOLE, PHYTOLACCA AMERICANA ROOT, MERCURIUS SOLUBILIS
Label structure11 sections

Dosage and administration

Adults/Children above 6 : spray 2 shots directly under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.

Storage and handling

Store at 59-77°F.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Phytolacca Decandra (Class N) 9C - Belladonna 9C - Mercurius Solubilis 9C.

TRADITIONALLY USED FOR

OTC - PURPOSE SECTION

This homeopathic medicine is made from a combination of ingredients traditionally used to relieve symptoms of Sore, Raw, Burning Throat.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Adults/Children above 6 : spray 2 shots directly under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.

USE

INDICATIONS & USAGE SECTION

PHYTOLACCA DECANDRA

Sore Throat with Pain Swallowing .*

BELLADONNA

Sudden Fever with Perspiration - Headache - Inflammation .*

MERCURIUS SOLUBILIS

Sore Throat with bad breath & Salivation .*

WARNINGS

WARNINGS SECTION

Consult a physician for use in children under 6 years of age.

Contact a doctor if symptoms persist.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

STORAGE AND HANDLING SECTION

Store at 59-77°F.

OTC - DO NOT USE SECTION

Do not use if seal is broken or missing.

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Organic Alcohol 20%

Purified Water

QUESTIONS?

OTC - QUESTIONS SECTION

Distributed by Sevene USA

East Troy, WI 53120 USA

1-855 - OLLOMED

QUESTIONS? info@ollois.com

www.ollois.com

MADE IN FRANCE.

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. No guarantee to be effective. A homeopathic dilution may not to be susceptible to scientific measurement. The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76472-700676472-7006-1, 76472-7006-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ATROPA BELLADONNA WHOLEDSV74G1P2JACTIB
PHYTOLACCA AMERICANA ROOT11E6VI8VEGACTIB
MERCURIUS SOLUBILIS324Y4038G2ACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

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
Throat Ease Sore throatPHYTOLACCA DECANDRA 9C, BELLADONNA 9C, MERCURIUS SOLUBILIS 9CSEVENE USA54eb5f38-45e2-859a-e063-6394a90a689a2026-08-18WarningsExact identifier
ndc (package): 76472-7006-1
ndc (package): 76472-7006-2
ndc (product): 76472-7006
ndc11 (package): 76472700601
ndc11 (package): 76472700602
spl id: 594f571e-58a6-48d5-e063-6394a90a198c
spl set id: 54eb5f38-45e2-859a-e063-6394a90a689a

Reported adverse events (FAERS/openFDA)#

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