Insomnia
- Manufacturer
- Newton Laboratories, Inc.
- Effective date
- 2021-07-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:41:11
Label at a glance#
ProductInsomnia
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 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 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.
OTC - ACTIVE INGREDIENT SECTION
Equal parts of Passiflora incarnata 11x, Valeriana officinalis 11x, Absinthium 15x, Anacardium orientale 15x, Argentum nitricum 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, Passiflora incarnata 15x, Pulsatilla 15x, Scutellaria lateriflora 15x, Sepia 15x, Thuja occidentalis 15x, 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 after waking.
INACTIVE INGREDIENT SECTION
Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.
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
Products#
Every source-derived product name is available through these pages.
- Insomnia
- 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
- SUCROSE
- 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
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55714-4703 | 55714-4703-1 |
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 |
|---|---|---|---|---|---|---|
| c6b74fc3-6778-7673-e053-2995a90a99da | b5a73fce-c53d-45f2-e053-2995a90ae440 | 2021-07-09 | Warnings | c6b74fc3-6778-7673-e053-2995a90a99da b5a73fce-c53d-45f2-e053-2995a90ae440 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.