I-Sleep: Homeopathic Product Information
I-SLEEP- wormwood, semecarpus anacardium juice, silver nitrate, arsenic trioxide, atropa belladonna, bryonia alba root, oyster shell calcium carbonate, crude, camphor (natural), matricaria chamomilla, black cohosh, cinchona officinalis bark, arabica coffee bean, cypripedium parviflorum var. pubescens root, gelsemium sempervirens root, hops, hyoscyamus niger, strychnos ignatii seed, potassium bromide, strychnos nux-vomica seed, passiflora incarnata flowering top, anemone pulsatilla, scutellaria lateriflora whole, sepia officinalis juice, thuja occidentalis leafy twig and valerian liquid
Newton Laboratories, Inc.
Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
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
I-SLEEP 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 liquid | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Labeler — Newton Laboratories, Inc. (788793610) |
Registrant — Newton Laboratories, Inc. (788793610) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Newton Laboratories, Inc. | 788793610 | manufacture (55714-2568) |
Revised: 02/2021 Newton Laboratories, Inc.
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