I-sleep 4844l

I-sleep 4844l
SPL v2
SPL
SPL Set ID c6f053fe-8b59-7226-e053-2995a90a8093
Route
ORAL
Published
Effective Date 2025-09-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Wormwood (20 [hp_X]) Semecarpus Anacardium Juice (11 [hp_X]) Silver Cation Arsenic Cation (3+) 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 Bromide Ion Strychnos Nux-vomica Seed Passiflora Incarnata Flowering Top Anemone Pulsatilla Scutellaria Lateriflora Whole Sepia Officinalis Juice Thuja Occidentalis Leafy Twig Valerian
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2021-02-01
Description

Formulated for symptoms associated with sleeplessness such as frequent waking, restlessness and the inability to fall asleep or return to sleep after waking.

Purpose

Formulated for symptoms associated with sleeplessness such as frequent waking, restlessness and the inability to fall asleep or return to sleep after waking.

Medication Information

Purpose

Formulated for symptoms associated with sleeplessness such as frequent waking, restlessness and the inability to fall asleep or return to sleep after waking.

Description

Formulated for symptoms associated with sleeplessness such as frequent waking, restlessness and the inability to fall asleep or return to sleep after waking.

Package Label

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.

Questions Section

newtonlabs.net – Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

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%.

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.

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 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.

Structured Label Content

Package Label (PACKAGE LABEL)

Warnings Section (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.

Questions Section (QUESTIONS SECTION)

newtonlabs.net – Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

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%.

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 Pregnancy Or Breast Feeding Section (OTC - PREGNANCY OR BREAST FEEDING SECTION)

If pregnant 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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:12:06.874756 · Updated: 2026-03-14T23:17:29.613906