Indications & Usage Section
Formulated for associated symptoms such as frequent waking, restlessness and the inability to fall asleep or return to sleep after waking.
I-sleep Liquid
FDA Label NDC 55714-4844
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Newton Laboratories, Inc. for the product I-sleep (NDC 55714-4844). 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 indications & usage section, dosage & administration section, otc - active ingredient section, otc - purpose section, inactive ingredient section, questions section, warnings section, otc - pregnancy or breast feeding section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
Otc - Active Ingredient Section
Equal parts of Passiflora incarnata 11x, Valeriana officinalis 11x, Absinthium 20x, Anacardium orientale 20x, Argentum nitricum 20x, Bryonia 20x, Calcarea carbonica 20x, Camphora 20x, Chamomilla 20x, Cimicifuga racemosa 20x, Cinchona officinalis 20x, Coffea cruda 20x, Cypripedium pubescen 20x, Gelsemium sempervirens 20x, Humulus lupulus 20x, Hyoscyamus niger 20x, Ignatia amara 20x, Kali bromatum 20x, Passiflora incarnata 20x, Pulsatilla 20x, Scutellaria lateriflora 20x, Sepia 20x, Thuja occidentalis 20x, Arsenicum album 20x, Belladonna 20x, Nux vomica 20x
Otc - Purpose Section
Formulated for associated symptoms 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
Package Label (R003 L01)
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