Simply Harmony

Simply Harmony is an FDA-registered drug product whose active ingredient is IGNATIA AMARA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, KALI PHOSPHORICUM. It is labelled by Nartex Laboratorios Homeopaticos, S.A. De C.V. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 34666-403, label effective 20211203. 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.

Across FDA labelling, products containing IGNATIA AMARA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, KALI PHOSPHORICUM are most often described in connection with: temporary relief, mental fatigue, difficulty concentrating, occasional sleeplessness, due everyday, hard-day periods, claims based, traditional homeopathic. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses For the temporary relief of mental fatigue, difficulty concentrating, headaches, and occasional sleeplessness due to everyday stress. For hard-day periods. Claims based on traditional homeopathic practice, not accepted medical evidence. These uses have not been evaluated by FDA, and product has not been clinically tested.

Directions adults and children 12 years and older: take 1 tablet every 8 hours. Dissolves slowly in mouth. children under 12 years, consult a physician.

Warnings Do not use if you have an allergy or hypersensitivity to the components of the formula or have had a prior reaction to this product. Stop use and ask a doctor if conditoin worsens. symptoms persist for more than 7 days or clear up and occur again within a few days. rash develops. If pregnant or breast feeding, consult a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

What is Simply Harmony used for?
Uses For the temporary relief of mental fatigue, difficulty concentrating, headaches, and occasional sleeplessness due to everyday stress. For hard-day periods. Claims based on traditional homeopathic practice, not accepted medical evidence. These uses have not been evaluated by FDA, and product has not been clinically tested.

Who makes Simply Harmony?
Nartex Laboratorios Homeopaticos, S.A. De C.V. is the labeler of record for Simply Harmony.

What form does Simply Harmony come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Simply Harmony 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 Simply Harmony 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.