I-Sleep
- Manufacturer
- Newton Laboratories, Inc.
- Effective date
- 2025-09-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 02:35:05
Label at a glance#
ProductI-Sleep
Active ingredientWORMWOOD, 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, VALERIAN
Label structure10 sections
Contacts and useful links#
Label contents#
Full prescribing information#
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 - 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
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 63f39a63-5cd1-4016-bd86-2bbb0f6c3139 | Product name | 3 | 20240506 |
| e5a77e9c-c528-733a-173d-914a234c024b | Product name | 5 | 20240506 |
| 6cca4355-1206-91f7-02de-17eef38a8622 | Product name | 1 | 20140508 |
| 751c581a-bf64-2fd7-b3ec-ca02c83e4a00 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55714-4844-1 | I-Sleep | 30 mL in 1 BOTTLE, GLASS | LIQUID | 30 | 2 |
Products#
Every source-derived product name is available through these pages.
- 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
- ALCOHOL
- WORMWOOD
- SEMECARPUS ANACARDIUM JUICE
- SILVER NITRATE
- SILVER CATION
- ARSENIC TRIOXIDE
- 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
- POTASSIUM BROMIDE
- BROMIDE ION
- STRYCHNOS NUX-VOMICA SEED
- PASSIFLORA INCARNATA FLOWERING TOP
- ANEMONE PULSATILLA
- SCUTELLARIA LATERIFLORA WHOLE
- SEPIA OFFICINALIS JUICE
- THUJA OCCIDENTALIS LEAFY TWIG
- VALERIAN
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55714-4844 | 55714-4844-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 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 | Newton Laboratories, Inc. | c6f053fe-8b59-7226-e053-2995a90a8093 | 2025-09-18 | Warnings | 55714-4844-1 55714-4844 55714484401 3f17fee1-6d69-aec2-e063-6294a90a02ed c6f053fe-8b59-7226-e053-2995a90a8093 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.