Simply Dreams

Simply Dreams is an FDA-registered drug product whose active ingredient is PASSIFLORA INCARNATA, VALERIANA OFFICINALIS. 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 34666-402, 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 PASSIFLORA INCARNATA, VALERIANA OFFICINALIS are most often described in connection with: difficulty falling, reduces time, fall asleep, relief occasional, sleeplessness intermittent, awakening helps, claims based, traditional homeopathic. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses Reduces time to fall asleep if you have difficulty falling asleep. For relief of occasional sleeplessness or intermittent awakening. Helps to reduce difficulty falling asleep. 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 2 tablets every 24 hours. Dissolves slowly in mouth. children under 12 years, do not use.

Warnings If sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness. 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. for children under 12 years of age. Stop use and ask a doctor if condition 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 Dreams used for?
Uses Reduces time to fall asleep if you have difficulty falling asleep. For relief of occasional sleeplessness or intermittent awakening. Helps to reduce difficulty falling asleep. 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 Dreams?
Nartex Laboratorios Homeopaticos, S.A. De C.V. is the labeler of record for Simply Dreams.

What form does Simply Dreams 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 Dreams 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 Dreams 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.