Calm mind Stress - Nervousness - Anxiety - Concentration

ACONITUM NAPELLUS 9C, CHAMOMILLA 9C, GELSEMIUM SEMPERVIRENS 9C, IGNATIA AMARA 9C, PASSIFLORA INCARNATA 3C, STRAMONIUM 9C BUCCAL HUMAN OTC DRUG

Calm mind Stress - Nervousness - Anxiety - Concentration is an FDA drug label for the active ingredient ACONITUM NAPELLUS 9C, CHAMOMILLA 9C, GELSEMIUM SEMPERVIRENS 9C, IGNATIA AMARA 9C, PASSIFLORA INCARNATA 3C, STRAMONIUM 9C 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 20260813.

Generic name
ACONITUM NAPELLUS 9C, CHAMOMILLA 9C, GELSEMIUM SEMPERVIRENS 9C, IGNATIA AMARA 9C, PASSIFLORA INCARNATA 3C, STRAMONIUM 9C
Manufacturer
SEVENE USA
Product type
HUMAN OTC DRUG
Route
BUCCAL
Dosage form
N/A
NDC
76472-7015
Application
N/A
Label effective
20260813

About this product

Calm mind Stress - Nervousness - Anxiety - Concentration is an FDA-registered drug product whose active ingredient is ACONITUM NAPELLUS 9C, CHAMOMILLA 9C, GELSEMIUM SEMPERVIRENS 9C, IGNATIA AMARA 9C, PASSIFLORA INCARNATA 3C, STRAMONIUM 9C. It is labelled by SEVENE USA taken by buccal and marketed as a human otc drug product. Identifiers on file: NDC 76472-7015, label effective 20260813. 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 ACONITUM NAPELLUS 9C, CHAMOMILLA 9C, GELSEMIUM SEMPERVIRENS 9C, IGNATIA AMARA 9C, PASSIFLORA INCARNATA 3C, STRAMONIUM 9C are most often described in connection with: aconitum napellus, sudden fever, cough associated, cold flu, chamomilla teething, pain- irritability, restlessness gelsemium, sempervirens apprehension. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

ACTIVE INGREDIENT: Aconitum Napellus 9C - Chamomilla 9C - Gelsemium Sempervirens 9C – Ignatia Amara 9C - Passiflora Incarnata (Class N) 3C - Stramonium 9C.

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 .*

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.

Warnings

Consult a physician for use in children under 6 years of age. Contact a doctor if symptoms persist.

Frequently asked questions

What is Calm mind Stress - Nervousness - Anxiety - Concentration used for?
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 …

Who makes Calm mind Stress - Nervousness - Anxiety - Concentration?
SEVENE USA is the labeler of record for Calm mind Stress - Nervousness - Anxiety - Concentration.

What form does Calm mind Stress - Nervousness - Anxiety - Concentration 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 Calm mind Stress - Nervousness - Anxiety - Concentration 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 Calm mind Stress - Nervousness - Anxiety - Concentration 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.