Insomnia
- Manufacturer
- Newton Laboratories, Inc.
- Effective date
- 2011-03-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 02:04:50
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
INDICATIONS & USAGE 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.
DOSAGE & ADMINISTRATION 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. Sensitive persons begin with 1 drop and gradually increase to full dose.
OTC - ACTIVE INGREDIENT SECTION
Absinthium 10x, Anacardium orientale 10x, Arg. nit. 10x, Arsenicum alb. 10x, Belladonna 10x, Bryonia 10x, Calc. carb. 10x, Camphora 10x, Chamomilla 10x, Cimicifuga 10x, Cinchona 10x, Coffea cruda 10x, Cypripedium 10x, Gelsemium 10x, Humulus 10x, Hyoscyamus 10x, Ignatia 10x, Kali brom.10x, Nux vom. 10x, Passiflora 10x, Pulsatilla 10x, Scutellaria lateriflora 10x, Sepia 10x, Thuja occ. 10x, Passiflora 3x, Valeriana 3x.
OTC - PURPOSE SECTION
Formulated for associated symptoms such as the inability to fall asleep as well as return to sleep after waking, frequent waking and restlessness.
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#
| 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55714-2246-0 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-1aaf-f424-e053-dadaa90a57ce | Insomnia |
| 55714-2246-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-1aaf-f424-e053-dadaa90a57ce | Insomnia |
| 55714-2246-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-1aaf-f424-e053-dadaa90a57ce | Insomnia |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55714-2246-0 | Insomnia | .5 mL in 1 BOTTLE, GLASS | LIQUID | .5 | 2 | |
| 55714-2246-1 | Insomnia | 29.57 mL in 1 BOTTLE, GLASS | LIQUID | 29.57 | 2 | |
| 55714-2246-2 | Insomnia | 59.14 mL in 1 BOTTLE, GLASS | LIQUID | 59.14 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55714-2246 | 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) LIQUID [NEWTON LABORATORIES, INC.] | 2 | Legacy NDC, 3 package rows | 20130808_1d54b655-d324-c12e-f7ef-f8c053d13f26.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Arabica Coffee Bean | ACTIVE INGREDIENT | 3SW678MX72 | 2 | |
| Arsenic Trioxide | ACTIVE INGREDIENT | S7V92P67HO | 2 | |
| Atropa Belladonna | ACTIVE INGREDIENT | WQZ3G9PF0H | 2 | |
| Black Cohosh | ACTIVE INGREDIENT | K73E24S6X9 | 2 | |
| Bryonia Alba Root | ACTIVE INGREDIENT | T7J046YI2B | 2 | |
| Camphor (natural) | ACTIVE INGREDIENT | N20HL7Q941 | 2 | |
| Cinchona Officinalis Bark | ACTIVE INGREDIENT | S003A158SB | 2 | |
| Cypripedium Parvifolum Root | ACTIVE INGREDIENT | 21Y9GZ1LZA | 2 | |
| Gelsemium Sempervirens Root | ACTIVE INGREDIENT | 639KR60Q1Q | 2 | |
| Hops | ACTIVE INGREDIENT | 01G73H6H83 | 2 | |
| Hyoscyamus Niger | ACTIVE INGREDIENT | 4WRK2153H3 | 2 | |
| Matricaria Recutita | ACTIVE INGREDIENT | G0R4UBI2ZZ | 2 | |
| Oyster Shell Calcium Carbonate, Crude | ACTIVE INGREDIENT | 2E32821G6I | 2 | |
| Passiflora Incarnata Flowering Top | ACTIVE INGREDIENT | CLF5YFS11O | 2 | |
| Potassium Bromide | ACTIVE INGREDIENT | OSD78555ZM | 2 | |
| Pulsatilla Vulgaris | ACTIVE INGREDIENT | I76KB35JEV | 2 | |
| Scutellaria Lateriflora | ACTIVE INGREDIENT | 7BP4DH5PDC | 2 | |
| Semecarpus Anacardium Juice | ACTIVE INGREDIENT | Y0F0BU8RDU | 2 | |
| Sepia Officinalis Juice | ACTIVE INGREDIENT | QDL83WN8C2 | 2 | |
| Silver Nitrate | ACTIVE INGREDIENT | 95IT3W8JZE | 2 | |
| Strychnos Ignatii Seed | ACTIVE INGREDIENT | 1NM3M2487K | 2 | |
| Strychnos Nux-vomica Seed | ACTIVE INGREDIENT | 269XH13919 | 2 | |
| Thuja Occidentalis Leafy Twig | ACTIVE INGREDIENT | 1NT28V9397 | 2 | |
| Valerian | ACTIVE INGREDIENT | JWF5YAW3QW | 2 | |
| Wormwood | ACTIVE INGREDIENT | F84709P2XV | 2 | |
| Arabica Coffee Bean | ACTIVE MOIETY | 3SW678MX72 | 2 | |
| Arsenic Cation (3+) | ACTIVE MOIETY | C96613F5AV | 2 | |
| Atropa Belladonna | ACTIVE MOIETY | WQZ3G9PF0H | 2 | |
| Black Cohosh | ACTIVE MOIETY | K73E24S6X9 | 2 | |
| Bromide Ion | ACTIVE MOIETY | 952902IX06 | 2 | |
| Bryonia Alba Root | ACTIVE MOIETY | T7J046YI2B | 2 | |
| Camphor (natural) | ACTIVE MOIETY | N20HL7Q941 | 2 | |
| Cinchona Officinalis Bark | ACTIVE MOIETY | S003A158SB | 2 | |
| Cypripedium Parvifolum Root | ACTIVE MOIETY | 21Y9GZ1LZA | 2 | |
| Gelsemium Sempervirens Root | ACTIVE MOIETY | 639KR60Q1Q | 2 | |
| Hops | ACTIVE MOIETY | 01G73H6H83 | 2 | |
| Hyoscyamus Niger | ACTIVE MOIETY | 4WRK2153H3 | 2 | |
| Matricaria Recutita | ACTIVE MOIETY | G0R4UBI2ZZ | 2 | |
| Oyster Shell Calcium Carbonate, Crude | ACTIVE MOIETY | 2E32821G6I | 2 | |
| Passiflora Incarnata Flowering Top | ACTIVE MOIETY | CLF5YFS11O | 2 | |
| Pulsatilla Vulgaris | ACTIVE MOIETY | I76KB35JEV | 2 | |
| Scutellaria Lateriflora | ACTIVE MOIETY | 7BP4DH5PDC | 2 | |
| Semecarpus Anacardium Juice | ACTIVE MOIETY | Y0F0BU8RDU | 2 | |
| Sepia Officinalis Juice | ACTIVE MOIETY | QDL83WN8C2 | 2 | |
| Silver Cation | ACTIVE MOIETY | 57N7B0K90A | 2 | |
| Strychnos Ignatii Seed | ACTIVE MOIETY | 1NM3M2487K | 2 | |
| Strychnos Nux-vomica Seed | ACTIVE MOIETY | 269XH13919 | 2 | |
| Thuja Occidentalis Leafy Twig | ACTIVE MOIETY | 1NT28V9397 | 2 | |
| Valerian | ACTIVE MOIETY | JWF5YAW3QW | 2 | |
| Wormwood | ACTIVE MOIETY | F84709P2XV | 2 | |
| Alcohol | INACTIVE INGREDIENT | 3K9958V90M | 2 |
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
- 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 Recutita
- Black Cohosh
- Cinchona Officinalis Bark
- Arabica Coffee Bean
- Cypripedium Parvifolum Root
- Gelsemium Sempervirens Root
- Hops
- Hyoscyamus Niger
- Strychnos Ignatii Seed
- Potassium Bromide
- Bromide Ion
- Strychnos Nux-vomica Seed
- Passiflora Incarnata Flowering Top
- Pulsatilla Vulgaris
- Scutellaria Lateriflora
- Sepia Officinalis Juice
- Thuja Occidentalis Leafy Twig
- Valerian
- Alcohol
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55714-2246 | 55714-2246-1, 55714-2246-2, 55714-2246-0 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / RESPIRATORY (INHALATION) | 0.08 %w/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | LIQUID / ORAL | 3563 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | LIQUID / RESPIRATORY (INHALATION) | 5 %w/w | ||
| Alcohol | ALCOHOL | 3K9958V90M | GEL, METERED / TRANSDERMAL | 3675 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SYRUP / ORAL | 21000 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SPRAY / SUBLINGUAL | 397 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION / SUBCUTANEOUS | 149 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | AEROSOL, SPRAY / RESPIRATORY (INHALATION) | 35.75 %w/w | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION / INTRAMUSCULAR | 1491 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SPRAY / TRANSDERMAL | 90 %w/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | PASTE / DENTAL | 1.8 %w/w | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / TOPICAL | 2445 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SUSPENSION / ORAL | 681 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / DENTAL | 12.8 %w/w | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION / INTRAVENOUS | 92 %w/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | AEROSOL, METERED / NASAL | 70 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | AEROSOL / NASAL | 20 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | GEL / RECTAL | 898 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION / INTRAVASCULAR | 100 %v/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | MOUTHWASH / BUCCAL | 200 mg/1ml | ||
| Alcohol | ALCOHOL | 3K9958V90M | SHAMPOO / TOPICAL | 714 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | AEROSOL, SPRAY / TOPICAL | 561 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | AEROSOL, FOAM / TOPICAL | 4504 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SPRAY / TOPICAL | 3633 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | GEL / DENTAL | 1.8 %w/w | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / SUBCUTANEOUS | 6.1 %v/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | SUSPENSION / RECTAL | 0.35 %v/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | CAPSULE / ORAL | 882 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | GEL / TOPICAL | 9971 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | CONCENTRATE / ORAL | 198 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | POWDER, FOR SOLUTION / TOPICAL | 40 %w/w | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION, CONCENTRATE / INTRAVENOUS | 4000 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SPRAY, METERED / SUBLINGUAL | 29 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | GEL, METERED / TOPICAL | 541 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SPRAY / NASAL | 20 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | DROPS / NASAL | 10 mg/1ml | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / NASAL | 10 mg/1ml | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / TRANSDERMAL | 49.37 %w/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION, EMULSION / INTRAVENOUS | 520 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | AEROSOL, METERED / RESPIRATORY (INHALATION) | 26664 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | LIQUID / INTRAMUSCULAR | 400 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | LOTION / TOPICAL | 25 %w/w | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION, CONCENTRATE / ORAL | 150.68 mg/1ml | ||
| Alcohol | ALCOHOL | 3K9958V90M | GEL / TRANSDERMAL | 7360 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / ORAL | 6624 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / INTRAVENOUS | 99 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / OPHTHALMIC | 0.5 %w/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | CONCENTRATE / BUCCAL | 679 mg/1ml | ||
| Alcohol | ALCOHOL | 3K9958V90M | DROPS / ORAL | 210 mg/1ml | ||
| Alcohol | ALCOHOL | 3K9958V90M | SWAB / TOPICAL | 2250 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | AEROSOL / TOPICAL | 561 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | JELLY / VAGINAL | NA | ||
| Alcohol | ALCOHOL | 3K9958V90M | ELIXIR / ORAL | 13675 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | LIQUID / INTRAVENOUS | 400 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | TABLET, DELAYED RELEASE / ORAL | NA | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / INTRAVESICAL | 7892 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | CAPSULE, EXTENDED RELEASE / ORAL | 8 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / INTRAMUSCULAR | 1000 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / INTRAVENOUS | 6405 mg |
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 |
|---|---|---|---|---|---|---|
| 14fce4e1-6dbf-367f-4968-ab8eb931c117 | 1d54b655-d324-c12e-f7ef-f8c053d13f26 | 2011-03-01 | Warnings | 14fce4e1-6dbf-367f-4968-ab8eb931c117 1d54b655-d324-c12e-f7ef-f8c053d13f26 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
