FDA Label for I-sleep
View Indications, Usage & Precautions
I-sleep Product Label
The following document was submitted to the FDA by the labeler of this product Newton Laboratories, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Indications & Usage Section
Formulated for symptoms associated with sleeplessness such as frequent waking, restlessness and the inability to fall asleep or return to sleep after waking.
Dosage & Administration Section
Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) one hour before bedtime, and then again at bedtime. Repeat as needed or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.
Otc - Active Ingredient Section
Equal parts of Passiflora incarnata 6x, Valeriana officinalis 6x, Absinthium 15x, Anacardium orientale 15x, Argentum nitricum 15x, Arsenicum album 15x, Belladonna 15x, Bryonia 15x, Calcarea carbonica 15x, Camphora 15x, Chamomilla 15x, Cimicifuga racemosa 15x, Cinchona officinalis 15x, Coffea cruda 15x, Cypripedium pubescens 15x, Gelsemium sempervirens 15x, Humulus lupulus 15x, Hyoscyamus niger 15x, Ignatia amara 15x, Kali bromatum 15x, Nux vomica 15x, Passiflora 15x, Pulsatilla 15x, Scutellaria 15x, Sepia 15x, Thuja occ. 15x.
Otc - Purpose Section
Formulated for symptoms associated with sleeplessness such as frequent waking, restlessness and the inability to fall asleep or return to sleep after waking.
Inactive Ingredient Section
Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.
Questions Section
newtonlabs.net - Questions? 800.448.7256
Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013
Warnings Section
WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.
Otc - Pregnancy Or Breast Feeding Section
If pregnant or breast-feeding, ask a doctor before use.
Otc - Keep Out Of Reach Of Children Section
Keep out of reach of children.
Package Label
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