INSOMNIA - wormwood, semecarpus anacardium juice, 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 and valerian liquid 
Newton Laboratories, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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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

Package Label

 

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
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-2246
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Wormwood (Wormwood) Wormwood10 [hp_X]  in 1 mL
Semecarpus Anacardium Juice (Semecarpus Anacardium Juice) Semecarpus Anacardium Juice10 [hp_X]  in 1 mL
Silver Nitrate (Silver Cation) Silver Nitrate10 [hp_X]  in 1 mL
Arsenic Trioxide (Arsenic Cation (3+)) Arsenic Trioxide10 [hp_X]  in 1 mL
Atropa Belladonna (Atropa Belladonna) Atropa Belladonna10 [hp_X]  in 1 mL
Bryonia Alba Root (Bryonia Alba Root) Bryonia Alba Root10 [hp_X]  in 1 mL
Oyster Shell Calcium Carbonate, Crude (Oyster Shell Calcium Carbonate, Crude) Oyster Shell Calcium Carbonate, Crude10 [hp_X]  in 1 mL
Camphor (natural) (Camphor (natural)) Camphor (natural)10 [hp_X]  in 1 mL
Matricaria Recutita (Matricaria Recutita) Matricaria Recutita10 [hp_X]  in 1 mL
Black Cohosh (Black Cohosh) Black Cohosh10 [hp_X]  in 1 mL
Cinchona Officinalis Bark (Cinchona Officinalis Bark) Cinchona Officinalis Bark10 [hp_X]  in 1 mL
Arabica Coffee Bean (Arabica Coffee Bean) Arabica Coffee Bean10 [hp_X]  in 1 mL
Cypripedium Parvifolum Root (Cypripedium Parvifolum Root) Cypripedium Parvifolum Root10 [hp_X]  in 1 mL
Gelsemium Sempervirens Root (Gelsemium Sempervirens Root) Gelsemium Sempervirens Root10 [hp_X]  in 1 mL
Hops (Hops) Hops10 [hp_X]  in 1 mL
Hyoscyamus Niger (Hyoscyamus Niger) Hyoscyamus Niger10 [hp_X]  in 1 mL
Strychnos Ignatii Seed (Strychnos Ignatii Seed) Strychnos Ignatii Seed10 [hp_X]  in 1 mL
Potassium Bromide (Potassium Cation) Potassium Bromide10 [hp_X]  in 1 mL
Strychnos Nux-vomica Seed (Strychnos Nux-vomica Seed) Strychnos Nux-vomica Seed10 [hp_X]  in 1 mL
Passiflora Incarnata Flowering Top (Passiflora Incarnata Flowering Top) Passiflora Incarnata Flowering Top10 [hp_X]  in 1 mL
Pulsatilla Vulgaris (Pulsatilla Vulgaris) Pulsatilla Vulgaris10 [hp_X]  in 1 mL
Scutellaria Lateriflora (Scutellaria Lateriflora) Scutellaria Lateriflora10 [hp_X]  in 1 mL
Sepia Officinalis Juice (Sepia Officinalis Juice) Sepia Officinalis Juice10 [hp_X]  in 1 mL
Thuja Occidentalis Leafy Twig (Thuja Occidentalis Leafy Twig) Thuja Occidentalis Leafy Twig10 [hp_X]  in 1 mL
Valerian (Valerian) Valerian3 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Alcohol 
Packaging
#Item CodePackage Description
1NDC:55714-2246-129.57 mL in 1 BOTTLE, GLASS
2NDC:55714-2246-259.14 mL in 1 BOTTLE, GLASS
3NDC:55714-2246-0.5 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/01/2011
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610MANUFACTURE(55714-2246), API MANUFACTURE(55714-2246)

Revised: 03/2011
 
Newton Laboratories, Inc.