Insomnia
- Manufacturer
- Newton Laboratories, Inc.
- Effective date
- 2011-06-01
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 02:03:36
Label at a glance#
ProductInsomnia
Active ingredientWormwood, Anacardium Occidentale Fruit, Silver Nitrate, Arsenic Trioxide, Atropa Belladonna, Bryonia Alba Root, Oyster Shell Calcium Carbonate, Crude, Camphor (natural), Matricaria Recutita, Black Cohosh, Cinchona Officinalis Bark, Arabica Coffee Bean, Cypripedium Parvifolum Root, Gelsemium Sempervirens Root, Hops, Hyoscyamus Niger, Strychnos Ignatii Seed, Potassium Bromide, Strychnos Nux-vomica Seed, Passiflora Incarnata Flowering Top, Pulsatilla Vulgaris, Scutellaria Lateriflora, Sepia Officinalis Juice, Thuja Occidentalis Leafy Twig, Valerian
Label structure9 sections
Contacts and useful links#
Websitewww.newtonlabs.net
www.newtonlabs.net
www.newtonlabs.netLabel contents#
Full prescribing information#
PRODUCT NAME & INDICATIONS SECTION
Insomnia Formulated for associated symptoms such as the inability to fall asleep as well as return to sleep after waking, frequent waking and restlessness.
DIRECTION SECTION
Directions: ORAL USE ONLY - SHAKE WELL. Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) one hour before bedtime, and then again at bedtime. Repeat as needed or as directed by a healthcare professional.
ACTIVE INGREDIENT SECTION
Absinthium 15x, Anacardium occidentale 15x, Arg. nit. 15x, Arsenicum alb. 15x, Belladonna 15x, Bryonia 15x,Calc. carb. 15x, Camphora 15x, Chamomilla 15x, Cimicifuga 15x, Cinchona 15x, Coffea cruda 15x, Cypripedium 15x, Gelsemium 15x,Humulus 15x, Hyoscyamus 15x, Ignatia 15x, Kali brom.15x, Nux vom. 15x, Passiflora 15x, Pulsatilla 15x, Scutellaria lateriflora 15x,Sepia 15x, Thuja occ. 15x, Passiflora 8x, Valeriana 8x, Passiflora 3x,Valeriana 3x.
INACTIVE INGREDIENT SECTION
Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.
QUESTIONS? SECTION
www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions? 1.800.448.7256
WARNINGS SECTION
Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.
OTC - PREGNANCY OR BREAST FEEDING SECTION
Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children
PACKAGE LABEL
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55714-4404-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-3eec-f424-e053-dadaa90a57ce | Insomnia |
| 55714-4404-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-3eec-f424-e053-dadaa90a57ce | Insomnia |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55714-4404-1 | Insomnia | 29.57 mL in 1 BOTTLE, GLASS | LIQUID | 29.57 | 1 | |
| 55714-4404-2 | Insomnia | 59.14 mL in 1 BOTTLE, GLASS | LIQUID | 59.14 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55714-4404 | INSOMNIA (ABSINTHIUM, ANACARDIUM OCCIDENTALE, ARG. NIT., ARSENICUM ALB., BELLADONNA, BRYONIA,CALC. CARB., CAMPHORA, CHAMOMILLA, CIMICIFUGA,CINCHONA, COFFEA CRUDA, CYPRIPEDIUM, GELSEMIUM,HUMULUS, HYOSCYAMUS, IGNATIA, KALI BROM., NUXVOM., PASSIFLORA, PULSATILLA, SCUTELLARIA LATERIFLORA,SEPIA, THUJA OCC., PASSIFLORA, ALERIANA, PASSIFLORA,VALERIANA) LIQUID [NEWTON LABORATORIES, INC.] | 1 | Legacy NDC, 2 package rows | 20120327_9dc40eda-2420-0a9b-cabe-172f38653fcb.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Anacardium Occidentale Fruit | ACTIVE INGREDIENT | 4A10JR4E7E | 1 | |
| Arabica Coffee Bean | ACTIVE INGREDIENT | 3SW678MX72 | 1 | |
| Arsenic Trioxide | ACTIVE INGREDIENT | S7V92P67HO | 1 | |
| Atropa Belladonna | ACTIVE INGREDIENT | WQZ3G9PF0H | 1 | |
| Black Cohosh | ACTIVE INGREDIENT | K73E24S6X9 | 1 | |
| Bryonia Alba Root | ACTIVE INGREDIENT | T7J046YI2B | 1 | |
| Camphor (natural) | ACTIVE INGREDIENT | N20HL7Q941 | 1 | |
| Cinchona Officinalis Bark | ACTIVE INGREDIENT | S003A158SB | 1 | |
| Cypripedium Parvifolum Root | ACTIVE INGREDIENT | 21Y9GZ1LZA | 1 | |
| Gelsemium Sempervirens Root | ACTIVE INGREDIENT | 639KR60Q1Q | 1 | |
| Hops | ACTIVE INGREDIENT | 01G73H6H83 | 1 | |
| Hyoscyamus Niger | ACTIVE INGREDIENT | 4WRK2153H3 | 1 | |
| Matricaria Recutita | ACTIVE INGREDIENT | G0R4UBI2ZZ | 1 | |
| Oyster Shell Calcium Carbonate, Crude | ACTIVE INGREDIENT | 2E32821G6I | 1 | |
| Passiflora Incarnata Flowering Top | ACTIVE INGREDIENT | CLF5YFS11O | 1 | |
| Potassium Bromide | ACTIVE INGREDIENT | OSD78555ZM | 1 | |
| Pulsatilla Vulgaris | ACTIVE INGREDIENT | I76KB35JEV | 1 | |
| Scutellaria Lateriflora | ACTIVE INGREDIENT | 7BP4DH5PDC | 1 | |
| Sepia Officinalis Juice | ACTIVE INGREDIENT | QDL83WN8C2 | 1 | |
| Silver Nitrate | ACTIVE INGREDIENT | 95IT3W8JZE | 1 | |
| Strychnos Ignatii Seed | ACTIVE INGREDIENT | 1NM3M2487K | 1 | |
| Strychnos Nux-vomica Seed | ACTIVE INGREDIENT | 269XH13919 | 1 | |
| Thuja Occidentalis Leafy Twig | ACTIVE INGREDIENT | 1NT28V9397 | 1 | |
| Valerian | ACTIVE INGREDIENT | JWF5YAW3QW | 1 | |
| Wormwood | ACTIVE INGREDIENT | F84709P2XV | 1 | |
| Anacardium Occidentale Fruit | ACTIVE MOIETY | 4A10JR4E7E | 1 | |
| Arabica Coffee Bean | ACTIVE MOIETY | 3SW678MX72 | 1 | |
| Arsenic Trioxide | ACTIVE MOIETY | S7V92P67HO | 1 | |
| Atropa Belladonna | ACTIVE MOIETY | WQZ3G9PF0H | 1 | |
| Black Cohosh | ACTIVE MOIETY | K73E24S6X9 | 1 | |
| Bryonia Alba Root | ACTIVE MOIETY | T7J046YI2B | 1 | |
| Camphor (natural) | ACTIVE MOIETY | N20HL7Q941 | 1 | |
| Cinchona Officinalis Bark | ACTIVE MOIETY | S003A158SB | 1 | |
| Cypripedium Parvifolum Root | ACTIVE MOIETY | 21Y9GZ1LZA | 1 | |
| Gelsemium Sempervirens Root | ACTIVE MOIETY | 639KR60Q1Q | 1 | |
| Hops | ACTIVE MOIETY | 01G73H6H83 | 1 | |
| Hyoscyamus Niger | ACTIVE MOIETY | 4WRK2153H3 | 1 | |
| Matricaria Recutita | ACTIVE MOIETY | G0R4UBI2ZZ | 1 | |
| Oyster Shell Calcium Carbonate, Crude | ACTIVE MOIETY | 2E32821G6I | 1 | |
| Passiflora Incarnata Flowering Top | ACTIVE MOIETY | CLF5YFS11O | 1 | |
| Potassium Cation | ACTIVE MOIETY | 295O53K152 | 1 | |
| Pulsatilla Vulgaris | ACTIVE MOIETY | I76KB35JEV | 1 | |
| Scutellaria Lateriflora | ACTIVE MOIETY | 7BP4DH5PDC | 1 | |
| Sepia Officinalis Juice | ACTIVE MOIETY | QDL83WN8C2 | 1 | |
| Silver Cation | ACTIVE MOIETY | 57N7B0K90A | 1 | |
| Strychnos Ignatii Seed | ACTIVE MOIETY | 1NM3M2487K | 1 | |
| Strychnos Nux-vomica Seed | ACTIVE MOIETY | 269XH13919 | 1 | |
| Thuja Occidentalis Leafy Twig | ACTIVE MOIETY | 1NT28V9397 | 1 | |
| Valerian | ACTIVE MOIETY | JWF5YAW3QW | 1 | |
| Wormwood | ACTIVE MOIETY | F84709P2XV | 1 |
Products#
Every source-derived product name is available through these pages.
- Insomnia
- Absinthium, Anacardium occidentale, Arg. nit., Arsenicum alb., Belladonna, Bryonia,Calc. carb., Camphora, Chamomilla, Cimicifuga,Cinchona, Coffea cruda, Cypripedium, Gelsemium,Humulus, Hyoscyamus, Ignatia, Kali brom., Nuxvom., Passiflora, Pulsatilla, Scutellaria lateriflora,Sepia, Thuja occ., Passiflora, aleriana, Passiflora,Valeriana
- Wormwood
- Anacardium Occidentale Fruit
- Silver Nitrate
- Silver Cation
- Arsenic Trioxide
- Atropa Belladonna
- Bryonia Alba Root
- Oyster Shell Calcium Carbonate, Crude
- Camphor (natural)
- Matricaria Recutita
- Black Cohosh
- Cinchona Officinalis Bark
- Arabica Coffee Bean
- Cypripedium Parvifolum Root
- Gelsemium Sempervirens Root
- Hops
- Hyoscyamus Niger
- Strychnos Ignatii Seed
- Potassium Bromide
- Potassium Cation
- Strychnos Nux-vomica Seed
- Passiflora Incarnata Flowering Top
- Pulsatilla Vulgaris
- Scutellaria Lateriflora
- Sepia Officinalis Juice
- Thuja Occidentalis Leafy Twig
- Valerian
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55714-4404 | 55714-4404-1, 55714-4404-2 |
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 |
|---|---|---|---|---|---|---|
| 063cfb19-5187-5b49-86e6-a441848f6c97 | 9dc40eda-2420-0a9b-cabe-172f38653fcb | 2011-06-01 | Warnings | 063cfb19-5187-5b49-86e6-a441848f6c97 9dc40eda-2420-0a9b-cabe-172f38653fcb |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.