Aquilegia Vulgaris, Avena Sativa, Chamomilla, Coffea Cruda, Cypripedium Pubescens, Humulus Lupulus, Hypericum Perforatum, Kali Phosphoricum, Melatonin, Melissa Officinalis, Natrum Muriaticum, Passiflora Incarnata, Valeriana Officinalis

FDA Drug Information • Also known as: Insomnia

Brand Names
Insomnia
Drug Class
Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC]
Route
ORAL
Product Type
HUMAN OTC DRUG

What 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 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.

Dosage and Administration

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 and Precautions

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.

About This Information

This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

What are side effects?

Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

What are drug interactions?

Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.