Insomnia

Insomnia
SPL v1
SPL
SPL Set ID 9dc40eda-2420-0a9b-cabe-172f38653fcb
Route
ORAL
Published
Effective Date 2012-01-23
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Wormwood (15 [hp_X]) Anacardium Occidentale Fruit (8 [hp_X]) Silver Cation (3 [hp_X]) 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 Cation Strychnos Nux-vomica Seed Passiflora Incarnata Flowering Top Pulsatilla Vulgaris Scutellaria Lateriflora Sepia Officinalis Juice Thuja Occidentalis Leafy Twig Valerian

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2011-06-01

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.


Medication Information

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.

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.

Questions? Section

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

Questions?  1.800.448.7256 

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%. 

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.

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.

Direction Section (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.

Questions? Section (QUESTIONS? SECTION)

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

Questions?  1.800.448.7256 

Active Ingredient Section (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 INGREDIENT SECTION)

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%. 

Product Name & Indications Section (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.

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)