Active Ingredient:
Aconitum Napellus 9C - Chamomilla 9C - Gelsemium Sempervirens 9C – Ignatia Amara 9C - Passiflora Incarnata (Class N) 3C - Stramonium 9C.
Calm Mind Spray
FDA Label NDC 76472-7015
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 Calm Mind (NDC 76472-7015). 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:, dosage & administration, indications & usage, 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:
- Nervousness (Emotional Sensitivity, Stress, Fatigue) and Minor Anxiety
- Fearful, Worry, Irritable, Listless, Brooding, Moody, Grief
- Night Terrors, Wakefulness
- Lack of Concentration
Dosage & 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.
Indications & Usage
ACONITUM NAPELLUS
Sudden Fever & Cough associated with Cold or Flu .*
CHAMOMILLA
Teething pain- Irritability - Restlessness .*
GELSEMIUM SEMPERVIRENS
Apprehension - Headache - Body Aches & Fever .*
IGNATIA AMARA
Sleeplessness, Nervousness, Hypersensitivity from Stress or Due to Emotional shock .*
PASSIFLORA INCARNATA
Restlessness - Sleeplessness .*
STRAMONIUM 9C
Sleeplessness with Intermittent Awakening - Night Fears .*
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.
