Smooth Breath Spasmodic cough
Smooth Breath Spasmodic cough is an FDA drug label for the active ingredient BRYONIA 5C, DROSERA 5C, MENTHA PIPERITA 3C, SPONGIA TOSTA 5C, VERBASCUM THAPSUS 3C, VIOLA ODORATA 3C manufactured by SEVENE USA administered by BUCCAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260818.
- Generic name
- BRYONIA 5C, DROSERA 5C, MENTHA PIPERITA 3C, SPONGIA TOSTA 5C, VERBASCUM THAPSUS 3C, VIOLA ODORATA 3C
- Manufacturer
- SEVENE USA
- Product type
- HUMAN OTC DRUG
- Route
- BUCCAL
- Dosage form
- N/A
- NDC
- 76472-7005
- Application
- N/A
- Label effective
- 20260818
About this product
Smooth Breath Spasmodic cough is an FDA-registered drug product whose active ingredient is BRYONIA 5C, DROSERA 5C, MENTHA PIPERITA 3C, SPONGIA TOSTA 5C, VERBASCUM THAPSUS 3C, VIOLA ODORATA 3C. It is labelled by SEVENE USA taken by buccal and marketed as a human otc drug product. Identifiers on file: NDC 76472-7005, label effective 20260818. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.
What it is used for
Across FDA labelling, products containing BRYONIA 5C, DROSERA 5C, MENTHA PIPERITA 3C, SPONGIA TOSTA 5C, VERBASCUM THAPSUS 3C, VIOLA ODORATA 3C are most often described in connection with: breathing difficulties, bryonia muscle, joint arthritis, pain aggravated, movement drosera, harsh painful, spasmodic cough, ramps mentha. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
USE 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 .*
Dosage & Administration
DIRECTIONS 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.
Warnings
WARNINGS Consult a physician for use in children under 6 years of age. Contact a doctor if symptoms persist.
Frequently asked questions
What is Smooth Breath Spasmodic cough used for?
USE 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 – …
Who makes Smooth Breath Spasmodic cough?
SEVENE USA is the labeler of record for Smooth Breath Spasmodic cough.
What form does Smooth Breath Spasmodic cough come in?
administered by buccal. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.
Is Smooth Breath Spasmodic cough prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.
Has Smooth Breath Spasmodic cough been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.
Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.