I-Sleep
I-Sleep 4844L
c6f053fe-8b59-7226-e053-2995a90a8093
HUMAN OTC DRUG LABEL
Sep 18, 2025
Newton Laboratories, Inc.
DUNS: 788793610
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Absinthium, Anacardium orientale, Arg. nit., Arsenicum alb., Belladonna, Bryonia, Calc. carb., Camphora, Chamomilla, Cimicifuga, Cinchona, Coffea cruda, Cypripedium, Gelsemium, Humulus, Hyoscyamus, Ignatia, Kali brom., Nux vom., Passiflora, Pulsatilla, Scutellaria lateriflora, Sepia, Thuja occ., Valeriana
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (27)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL
INDICATIONS & USAGE SECTION
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
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
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
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 INGREDIENT SECTION
Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.
OTC - QUESTIONS SECTION
QUESTIONS SECTION
newtonlabs.net – Questions? 800.448.7256
Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013
WARNINGS SECTION
WARNINGS SECTION
WARNINGS: Keep out of reach of children.** Do not useif tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. Ifpregnant or breast-feeding**, ask a doctor before use.
OTC - PREGNANCY OR BREAST FEEDING SECTION
OTC - PREGNANCY OR BREAST FEEDING SECTION
Ifpregnant or breast-feeding, ask a doctor before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.