Insomnia

Insomnia
SPL v1
SPL
SPL Set ID d4e15024-749a-becb-3c16-dff43a0d9b95
Route
ORAL
Published
Effective Date 2012-10-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Wormwood (10 [hp_X]) Semecarpus Anacardium Juice (3 [hp_X]) Silver Cation 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 Bromide Ion Strychnos Nux-vomica Seed Passiflora Incarnata Flowering Top Pulsatilla Vulgaris Scutellaria Lateriflora Sepia Officinalis Juice Thuja Occidentalis Leafy Twig Valerian
Inactive Ingredients
Sucrose

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2011-03-01
Description

Insomnia  Formulated for associated symptoms such as the inability to fall asleep as well as return to sleep after waking, frequent waking and restlessness.

Purpose

Formulated for associated symptoms such as the inability to fall asleep as well as return to sleep after waking, frequent waking and restlessness.

Medication Information

Purpose

Formulated for associated symptoms such as the inability to fall asleep as well as return to sleep after waking, frequent waking and restlessness.

Description

Insomnia  Formulated for associated symptoms such as the inability to fall asleep as well as return to sleep after waking, frequent waking and restlessness.

Package Label

 

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.

Questions Section

www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012

Questions?  1.800.448.7256

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: Gluten-free, non-GMO, beet-derived sucrose pellets.

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:  Ages 12 and up, take 6 pellets orally (ages 0 to 11, give 3 pellets) one hour before bedtime, and then again at bedtime. Repeat as needed or as directed by a healthcare professional. Under age 2, crush or dissolve pellets in purified water.  Sensitive persons begin with 1 pellet 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 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.

Structured Label Content

Package Label (PACKAGE LABEL)

 

Warnings Section (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.

Questions Section (QUESTIONS SECTION)

www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012

Questions?  1.800.448.7256

Otc Purpose Section (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 INGREDIENT SECTION)

Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets.

Indications & Usage Section (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 (DOSAGE & ADMINISTRATION SECTION)

Directions:  Ages 12 and up, take 6 pellets orally (ages 0 to 11, give 3 pellets) one hour before bedtime, and then again at bedtime. Repeat as needed or as directed by a healthcare professional. Under age 2, crush or dissolve pellets in purified water.  Sensitive persons begin with 1 pellet and gradually increase to full dose.

Otc Active Ingredient Section (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 Pregnancy Or Breast Feeding Section (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 (OTC - KEEP OUT OF REACH OF CHILDREN SECTION)

Keep out of reach of children.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:09:14.525178 · Updated: 2026-03-14T23:14:26.587869