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

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55714-2568 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WORMWOOD (WORMWOOD) WORMWOOD 15 [hp_X] in 1 mL SEMECARPUS ANACARDIUM JUICE (SEMECARPUS ANACARDIUM JUICE) SEMECARPUS ANACARDIUM JUICE 15 [hp_X] in 1 mL SILVER NITRATE (SILVER CATION) SILVER NITRATE 15 [hp_X] in 1 mL ARSENIC TRIOXIDE (ARSENIC CATION (3+)) ARSENIC TRIOXIDE 15 [hp_X] in 1 mL ATROPA BELLADONNA (ATROPA BELLADONNA) ATROPA BELLADONNA 15 [hp_X] in 1 mL BRYONIA ALBA ROOT (BRYONIA ALBA ROOT) BRYONIA ALBA ROOT 15 [hp_X] in 1 mL OYSTER SHELL CALCIUM CARBONATE, CRUDE (OYSTER SHELL CALCIUM CARBONATE, CRUDE) OYSTER SHELL CALCIUM CARBONATE, CRUDE 15 [hp_X] in 1 mL CAMPHOR (NATURAL) (CAMPHOR (NATURAL)) CAMPHOR (NATURAL) 15 [hp_X] in 1 mL MATRICARIA CHAMOMILLA (MATRICARIA CHAMOMILLA) MATRICARIA CHAMOMILLA 15 [hp_X] in 1 mL BLACK COHOSH (BLACK COHOSH) BLACK COHOSH 15 [hp_X] in 1 mL CINCHONA OFFICINALIS BARK (CINCHONA OFFICINALIS BARK) CINCHONA OFFICINALIS BARK 15 [hp_X] in 1 mL ARABICA COFFEE BEAN (ARABICA COFFEE BEAN) ARABICA COFFEE BEAN 15 [hp_X] in 1 mL CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT (CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT) CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT 15 [hp_X] in 1 mL GELSEMIUM SEMPERVIRENS ROOT (GELSEMIUM SEMPERVIRENS ROOT) GELSEMIUM SEMPERVIRENS ROOT 15 [hp_X] in 1 mL HOPS (HOPS) HOPS 15 [hp_X] in 1 mL HYOSCYAMUS NIGER (HYOSCYAMUS NIGER) HYOSCYAMUS NIGER 15 [hp_X] in 1 mL STRYCHNOS IGNATII SEED (STRYCHNOS IGNATII SEED) STRYCHNOS IGNATII SEED 15 [hp_X] in 1 mL POTASSIUM BROMIDE (BROMIDE ION) POTASSIUM BROMIDE 15 [hp_X] in 1 mL STRYCHNOS NUX-VOMICA SEED (STRYCHNOS NUX-VOMICA SEED) STRYCHNOS NUX-VOMICA SEED 15 [hp_X] in 1 mL PASSIFLORA INCARNATA FLOWERING TOP (PASSIFLORA INCARNATA FLOWERING TOP) PASSIFLORA INCARNATA FLOWERING TOP 15 [hp_X] in 1 mL ANEMONE PULSATILLA (ANEMONE PULSATILLA) ANEMONE PULSATILLA 15 [hp_X] in 1 mL SCUTELLARIA LATERIFLORA WHOLE (SCUTELLARIA LATERIFLORA WHOLE) SCUTELLARIA LATERIFLORA WHOLE 15 [hp_X] in 1 mL SEPIA OFFICINALIS JUICE (SEPIA OFFICINALIS JUICE) SEPIA OFFICINALIS JUICE 15 [hp_X] in 1 mL THUJA OCCIDENTALIS LEAFY TWIG (THUJA OCCIDENTALIS LEAFY TWIG) THUJA OCCIDENTALIS LEAFY TWIG 15 [hp_X] in 1 mL VALERIAN (VALERIAN) VALERIAN 6 [hp_X] in 1 mL

Inactive Ingredients Ingredient Name Strength ALCOHOL WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:55714-2568-1 30 mL in 1 BOTTLE, GLASS None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 02/01/2021

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.