Insomnia

Insomnia is an FDA-registered drug product whose active ingredient is AQUILEGIA VULGARIS, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HUMULUS LUPULUS, HYPERICUM PERFORATUM, KALI PHOSPHORICUM, MELATONIN, MELISSA OFFICINALIS, NATRUM MURIATICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS. It is labelled by Liddell Laboratories, Inc. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 50845-0272, label effective 20231031. 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 AQUILEGIA VULGARIS, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HUMULUS LUPULUS, HYPERICUM PERFORATUM, KALI PHOSPHORICUM, MELATONIN, MELISSA OFFICINALIS, NATRUM MURIATICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS are most often described in connection with: temporarily relieve, symptoms associated, occasional sleeplessness, caused anxiety, restlessness stress, caffeine sensitivity, claims based, traditional homeopathic. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

USES: May temporarily relieve symptoms associated with occasional sleeplessness caused by: anxiety, restlessness, stress, and caffeine sensitivity** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

DIRECTIONS: Adults and children over 12: Two sprays under the tongue prior to bedtime and when sleep is interrupted by restlessness. Children under 12: Consult a doctor prior to use.

WARNINGS: See box. Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Stop use and ask a doctor if symptoms persist for more than 7 days, worsen, or if new symptoms occur. Keep out of reach of children. In case of overdose, get medical help or call a Poison Control Center right away. If pregnant or breast feeding, ask a doctor before using product. Do not use if TAMPER EVIDENT seal around neck of bottle is missing or broken. Store at room temperature.

What is Insomnia used for?
USES: May temporarily relieve symptoms associated with occasional sleeplessness caused by: anxiety, restlessness, stress, and caffeine sensitivity** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Who makes Insomnia?
Liddell Laboratories, Inc. is the labeler of record for Insomnia.

What form does Insomnia 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 Insomnia 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 Insomnia 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.