Guna-sleep Solution/ Drops
FDA Label NDC 17089-294

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Guna Spa for the product Guna-sleep (NDC 17089-294). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, otc - when using, otc - questions, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Avena sativa    6c    Nervousness
Chamomilla    6c    Restlessness
Helleborus niger    6c    Mental stress
Ignatia amara    6c    Restlessness
Interleukin 1 beta    4c    IMMUNE SUPPORT
Melatonin    4c    Hormonal regulation
Melissa officinalis    6c    Anxiety
Pineal gland    6x 12x 30x    Hormonal regulation
Pulsatilla     6c    Mood support
Serotonin    6c    Hormonal support
Valeriana officinalis    6c    Restlessness

Otc - Purpose

For the temporary relief of difficulty falling asleep

Otc - Stop Use

Stop use and ask doctor if sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding ask a doctor before use

Otc - Keep Out Of Reach Of Children

Keep this and all medicines out of reach of children

Otc - When Using

Take 1 hour after evening meal
Adults and children 12 years and older    20 drops in a little water
Children between 12 years and 6 years of age    10 drops in a little water
Children under 6 years    5 drops in a glass of water

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