SEVENE USA - Smooth Breath - Spasmodic cough

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 02:00:56

Label at a glance#

ProductSmooth Breath Spasmodic cough
Active ingredientVERBASCUM THAPSUS WHOLE, DROSERA ROTUNDIFOLIA WHOLE, BRYONIA CRETICA SUBSP. DIOICA ROOT, MENTHA PIPERITA, SPONGIA OFFICINALIS WHOLE, VIOLA ODORATA WHOLE
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

Bryonia 5C - Drosera 5C - Mentha Piperita 3C - Spongia Tosta 5C – Verbascum Thapsus 3C - Viola Odorata 3C.

TRADITIONALLY USED FOR

OTC - PURPOSE SECTION

This homeopathic medicine is made from a combination of ingredients traditionally used to relieve symptoms of:

- Dry, Irritating, Spasmodic Cough

- Dry, Sore Throat & Hoarseness

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

BRYONIA

Muscle and Joint/Arthritis Pain Aggravated by Movement .*

DROSERA

Harsh Painful (Spasmodic) Cough - ramps .*

MENTHA PIPERITA

Digestive Discomfort (Gas, Colic) – Dry Cough & Throat Irritation Aggravated by Cold or Smoke - Skin Discomfort (Itching or Sensitivity) .*

SPONGIA TOSTA

Breathing Difficulties associated with Barking Cough .*

VERBASCUM THAPSUS

Earaches - Deep Harsh Coughs – Facial Pain with Stuffy Nose .*

VIOLA ODORATA

Ear disorders - Frontal headaches - Spasmodic coughs – Breathing Difficulties - Right-sided Rheumatic Pains .*

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#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76472-700576472-7005-1, 76472-7005-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
Smooth Breath Spasmodic coughBRYONIA 5C, DROSERA 5C, MENTHA PIPERITA 3C, SPONGIA TOSTA 5C, VERBASCUM THAPSUS 3C, VIOLA ODORATA 3CSEVENE USA54eb17ad-c834-db86-e063-6294a90a58972026-08-18WarningsExact identifier
ndc (package): 76472-7005-1
ndc (package): 76472-7005-2
ndc (product): 76472-7005
ndc11 (package): 76472700502
ndc11 (package): 76472700501
spl id: 594f58b9-1210-49ee-e063-6394a90a5f97
spl set id: 54eb17ad-c834-db86-e063-6294a90a5897

Reported adverse events (FAERS/openFDA)#

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