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., nux vom., passiflora, pulsatilla, scutellaria lateriflora, sepia, thuja occ., valeriana pellet

Insomnia by

Drug Labeling and Warnings

Insomnia by is a Homeopathic medication manufactured, distributed, or labeled by Newton Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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. 

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

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.

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.

KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

PACKAGE LABEL

INGREDIENTS AND APPEARANCE

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., nux vom., passiflora, pulsatilla, scutellaria lateriflora, sepia, thuja occ., valeriana pellet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 55714-4405
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Wormwood (UNII: F84709P2XV) (Wormwood - UNII:F84709P2XV)	Wormwood	15 [hp_X]  in 1 g
Semecarpus Anacardium Juice (UNII: Y0F0BU8RDU) (Semecarpus Anacardium Juice - UNII:Y0F0BU8RDU)	Semecarpus Anacardium Juice	15 [hp_X]  in 1 g
Silver Nitrate (UNII: 95IT3W8JZE) (Silver Cation - UNII:57N7B0K90A)	Silver Nitrate	15 [hp_X]  in 1 g
Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV)	Arsenic Trioxide	15 [hp_X]  in 1 g
Atropa Belladonna (UNII: WQZ3G9PF0H) (Atropa Belladonna - UNII:WQZ3G9PF0H)	Atropa Belladonna	15 [hp_X]  in 1 g
Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B)	Bryonia Alba Root	15 [hp_X]  in 1 g
Oyster Shell Calcium Carbonate, Crude (UNII: 2E32821G6I) (Oyster Shell Calcium Carbonate, Crude - UNII:2E32821G6I)	Oyster Shell Calcium Carbonate, Crude	15 [hp_X]  in 1 g
Camphor (natural) (UNII: N20HL7Q941) (Camphor (natural) - UNII:N20HL7Q941)	Camphor (natural)	15 [hp_X]  in 1 g
Matricaria Recutita (UNII: G0R4UBI2ZZ) (Matricaria Recutita - UNII:G0R4UBI2ZZ)	Matricaria Recutita	15 [hp_X]  in 1 g
Black Cohosh (UNII: K73E24S6X9) (Black Cohosh - UNII:K73E24S6X9)	Black Cohosh	15 [hp_X]  in 1 g
Cinchona Officinalis Bark (UNII: S003A158SB) (Cinchona Officinalis Bark - UNII:S003A158SB)	Cinchona Officinalis Bark	15 [hp_X]  in 1 g
Arabica Coffee Bean (UNII: 3SW678MX72) (Arabica Coffee Bean - UNII:3SW678MX72)	Arabica Coffee Bean	15 [hp_X]  in 1 g
Cypripedium Parvifolum Root (UNII: 21Y9GZ1LZA) (Cypripedium Parvifolum Root - UNII:21Y9GZ1LZA)	Cypripedium Parvifolum Root	15 [hp_X]  in 1 g
Gelsemium Sempervirens Root (UNII: 639KR60Q1Q) (Gelsemium Sempervirens Root - UNII:639KR60Q1Q)	Gelsemium Sempervirens Root	15 [hp_X]  in 1 g
Hops (UNII: 01G73H6H83) (Hops - UNII:01G73H6H83)	Hops	15 [hp_X]  in 1 g
Hyoscyamus Niger (UNII: 4WRK2153H3) (Hyoscyamus Niger - UNII:4WRK2153H3)	Hyoscyamus Niger	15 [hp_X]  in 1 g
Strychnos Ignatii Seed (UNII: 1NM3M2487K) (Strychnos Ignatii Seed - UNII:1NM3M2487K)	Strychnos Ignatii Seed	15 [hp_X]  in 1 g
Potassium Bromide (UNII: OSD78555ZM) (Bromide Ion - UNII:952902IX06)	Potassium Bromide	15 [hp_X]  in 1 g
Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919)	Strychnos Nux-vomica Seed	15 [hp_X]  in 1 g
Passiflora Incarnata Flowering Top (UNII: CLF5YFS11O) (Passiflora Incarnata Flowering Top - UNII:CLF5YFS11O)	Passiflora Incarnata Flowering Top	15 [hp_X]  in 1 g
Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV)	Pulsatilla Vulgaris	15 [hp_X]  in 1 g
Scutellaria Lateriflora (UNII: 7BP4DH5PDC) (Scutellaria Lateriflora - UNII:7BP4DH5PDC)	Scutellaria Lateriflora	15 [hp_X]  in 1 g
Sepia Officinalis Juice (UNII: QDL83WN8C2) (Sepia Officinalis Juice - UNII:QDL83WN8C2)	Sepia Officinalis Juice	15 [hp_X]  in 1 g
Thuja Occidentalis Leafy Twig (UNII: 1NT28V9397) (Thuja Occidentalis Leafy Twig - UNII:1NT28V9397)	Thuja Occidentalis Leafy Twig	15 [hp_X]  in 1 g
Valerian (UNII: JWF5YAW3QW) (Valerian - UNII:JWF5YAW3QW)	Valerian	8 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Sucrose (UNII: C151H8M554)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55714-4405-1	28.35 g in 1 BOTTLE, GLASS
2	NDC: 55714-4405-2	56.7 g in 1 BOTTLE, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		06/01/2011

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Establishment
Name	Address	ID/FEI	Business Operations
Newton Laboratories, Inc.		788793610	MANUFACTURE(55714-4405)