Active Ingredient
Bryonia 5C - Drosera 5C - Mentha Piperita 3C - Spongia Tosta 5C – Verbascum Thapsus 3C - Viola Odorata 3C.
Smooth Breath Spray
FDA Label NDC 76472-7005
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sevene Usa for the product Smooth Breath (NDC 76472-7005). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, traditionally used for, directions, use, warnings, otc - keep out of reach of children, storage and handling, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Traditionally Used For
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
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
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
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
Keep out of reach of children.
Storage And Handling
Store at 59-77°F.
Otc - Do Not Use
Do not use if seal is broken or missing.
Inactive Ingredient
Organic Alcohol 20%
Purified Water
Questions?
Distributed by Sevene USA
East Troy, WI 53120 USA
1-855 - OLLOMED
QUESTIONS? [email protected]
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.
* Please review the disclaimer below.
