FDA.reportPublic FDA data

I-Sleep

Manufacturer
Newton Laboratories, Inc.
Effective date
2021-02-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:14:38

Label at a glance#

ProductI-Sleep
Active ingredientWORMWOOD, SEMECARPUS ANACARDIUM JUICE, SILVER NITRATE, ARSENIC TRIOXIDE, ATROPA BELLADONNA, MATRICARIA CHAMOMILLA, BRYONIA ALBA ROOT, OYSTER SHELL CALCIUM CARBONATE, CRUDE, CAMPHOR (NATURAL), 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, SEPIA OFFICINALIS JUICE, PASSIFLORA INCARNATA FLOWERING TOP, ANEMONE PULSATILLA, SCUTELLARIA LATERIFLORA WHOLE, THUJA OCCIDENTALIS LEAFY TWIG, VALERIAN
Label structure10 sections

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 pellets by mouth (ages 0 to 11, give 3 pellets) one hour before bedtime, and then again at bedtime. Repeat as needed or as directed by a health professional. Under age 2, crush/dissolve pellets in purified water. Sensitive persons begin with 1 pellet 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 incarnata 15x, Pulsatilla 15x, Scutellaria lateriflora 15x, Sepia 15x, Thuja occidentalis 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 after waking.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.

QUESTIONS SECTION

OTC - 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2569-1I-Sleep28 g in 1 BOTTLE, GLASSPELLET281

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2569I-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) PELLET [NEWTON LABORATORIES, INC.]1Current NDC, Legacy NDC, 1 package rows20210709_c6a1163c-b21e-6474-e053-2995a90a1750.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-256955714-2569-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUCROSEC151H8M554IACT
WORMWOODF84709P2XVACTIB
SEMECARPUS ANACARDIUM JUICEY0F0BU8RDUACTIB
SILVER NITRATE95IT3W8JZEACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
MATRICARIA CHAMOMILLAG0R4UBI2ZZACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
OYSTER SHELL CALCIUM CARBONATE, CRUDE2E32821G6IACTIB
CAMPHOR (NATURAL)N20HL7Q941ACTIB
BLACK COHOSHK73E24S6X9ACTIB
CINCHONA OFFICINALIS BARKS003A158SBACTIB
ARABICA COFFEE BEAN3SW678MX72ACTIB
CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT21Y9GZ1LZAACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
HOPS01G73H6H83ACTIB
HYOSCYAMUS NIGER4WRK2153H3ACTIB
STRYCHNOS IGNATII SEED1NM3M2487KACTIB
POTASSIUM BROMIDEOSD78555ZMACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
PASSIFLORA INCARNATA FLOWERING TOPCLF5YFS11OACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB
SCUTELLARIA LATERIFLORA WHOLE7BP4DH5PDCACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB
VALERIANJWF5YAW3QWACTIB

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
I-SleepABSINTHIUM, 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., VALERIANANewton Laboratories, Inc.c6a1163c-b21e-6474-e053-2995a90a17502021-02-01WarningsExact identifier
ndc (package): 55714-2569-1
ndc (product): 55714-2569
ndc11 (package): 55714256901
spl id: c6a0f7de-6eae-1ef8-e053-2995a90ad239
spl set id: c6a1163c-b21e-6474-e053-2995a90a1750

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.