Country: United States
Language: English
Source: NLM (National Library of Medicine)
WORMWOOD (UNII: F84709P2XV) (WORMWOOD - UNII:F84709P2XV), SEMECARPUS ANACARDIUM JUICE (UNII: Y0F0BU8RDU) (SEMECARPUS ANACARDIUM JUICE - UNII:Y0F0BU8RDU), SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A), ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV), ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H), BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B), OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6
Newton Laboratories, Inc.
ORAL
OTC DRUG
Formulated for associated symptoms such as frequent waking, restlessness and the inability to fall asleep or return to sleep after waking. Formulated for associated symptoms such as frequent waking, restlessness and the inability to fall asleep or return to sleep after waking.
unapproved homeopathic
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 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._ ---------- I-SLEEP 4844L INDICATIONS & USAGE SECTION Formulated for associated symptoms 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. 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 newtonlabs.net – Questions? 800.448.7256 Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013 WARNINGS SECTION WARNINGS: KEEP OUT OF Read the complete document