INDICATIONS & USAGE SECTION

Diarrhea Formulated for associated symptoms such as loose or watery stools, cramping, gas, nausea, irritation and fatigue.

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL. Children, ages 0 to 11, give 3 drops orally (ages 12 and up, give 6 drops) 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

Aconitum nap. 15x, Arg. nit. 15x, Arsenicum alb. 15x, Baptisia 15x, Bryonia 15x, Carbo veg. 15x, Chamomilla 15x, Cinchona 15x, Collinsonia 15x, Colocynthis 15x, Elaterium 15x, Gelsemium 15x, Ipecac. 15x, Iris versicolor 15x, Lycopodium 15x, Mag. carb. 15x, Phosphorus 15x, Podoph. pelt. 15x, Rheum 15x, Sulphur 15x, Tabacum 15x, Vaccinium 15x, Aesculus hipp. 3x, Juglans regia 3x, Valeriana 3x.

OTC - PURPOSE SECTION

Formulated for associated symptoms such as loose or watery stools, cramping, gas, nausea, irritation and fatigue.

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

DIARRHEA
aconitum nap., arg. nit., arsenicum alb., baptisia, bryonia, carbo veg., chamomilla, cinchona, collinsonia, colocynthis, elaterium, gelsemium, ipecac., iris versicolor, lycopodium, mag. carb., phosphorus, podoph. pelt., rheum, sulphur, tabacum, vaccinium, aesculus hipp. juglans regia, valeriana liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55714-1511
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Aconitum Napellus (UNII: U0NQ8555JD) (Aconitum Napellus - UNII:U0NQ8555JD)	Aconitum Napellus	15 [hp_X] in 1 mL
Silver Nitrate (UNII: 95IT3W8JZE) (Silver Cation - UNII:57N7B0K90A)	Silver Nitrate	15 [hp_X] in 1 mL
Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV)	Arsenic Trioxide	15 [hp_X] in 1 mL
Baptisia Tinctoria (UNII: 5K1UO2888Y) (Baptisia Tinctoria - UNII:5K1UO2888Y)	Baptisia Tinctoria	15 [hp_X] in 1 mL
Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B)	Bryonia Alba Root	15 [hp_X] in 1 mL
Activated Charcoal (UNII: 2P3VWU3H10) (Activated Charcoal - UNII:2P3VWU3H10)	Activated Charcoal	15 [hp_X] in 1 mL
Matricaria Recutita (UNII: G0R4UBI2ZZ) (Matricaria Recutita - UNII:G0R4UBI2ZZ)	Matricaria Recutita	15 [hp_X] in 1 mL
Cinchona Officinalis Bark (UNII: S003A158SB) (Cinchona Officinalis Bark - UNII:S003A158SB)	Cinchona Officinalis Bark	15 [hp_X] in 1 mL
Collinsonia Canadensis Root (UNII: O2630F3XDR) (Collinsonia Canadensis Root - UNII:O2630F3XDR)	Collinsonia Canadensis Root	15 [hp_X] in 1 mL
Citrullus Colocynthis Fruit Pulp (UNII: 23H32AOH17) (Citrullus Colocynthis Fruit Pulp - UNII:23H32AOH17)	Citrullus Colocynthis Fruit Pulp	15 [hp_X] in 1 mL
Ecballium Elaterium Fruit (UNII: 8P8HWT6ZWC) (Ecballium Elaterium Fruit - UNII:8P8HWT6ZWC)	Ecballium Elaterium Fruit	15 [hp_X] in 1 mL
Gelsemium Sempervirens Root (UNII: 639KR60Q1Q) (Gelsemium Sempervirens Root - UNII:639KR60Q1Q)	Gelsemium Sempervirens Root	15 [hp_X] in 1 mL
Ipecac (UNII: 62I3C8233L) (Ipecac - UNII:62I3C8233L)	Ipecac	15 [hp_X] in 1 mL
Iris Versicolor Root (UNII: X43D4L3DQC) (Iris Versicolor Root - UNII:X43D4L3DQC)	Iris Versicolor Root	15 [hp_X] in 1 mL
Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479)	Lycopodium Clavatum Spore	15 [hp_X] in 1 mL
Magnesium Carbonate (UNII: 0E53J927NA) (Carbonate Ion - UNII:7UJQ5OPE7D)	Magnesium Carbonate	15 [hp_X] in 1 mL
Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W)	Phosphorus	15 [hp_X] in 1 mL
Podophyllum (UNII: 2S713A4VP3) (Podophyllum - UNII:2S713A4VP3)	Podophyllum	15 [hp_X] in 1 mL
Rheum Officinale Whole (UNII: VC3KP6B2CE) (Rheum Officinale Whole - UNII:VC3KP6B2CE)	Rheum Officinale Whole	15 [hp_X] in 1 mL
Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70)	Sulfur	15 [hp_X] in 1 mL
Tobacco Leaf (UNII: 6YR2608RSU) (Tobacco Leaf - UNII:6YR2608RSU)	Tobacco Leaf	15 [hp_X] in 1 mL
Bilberry (UNII: 9P2U39H18W) (Bilberry - UNII:9P2U39H18W)	Bilberry	15 [hp_X] in 1 mL
Horse Chestnut (UNII: 3C18L6RJAZ) (Horse Chestnut - UNII:3C18L6RJAZ)	Horse Chestnut	3 [hp_X] in 1 mL
Juglans Regia Whole (UNII: 87EJ76IO83) (Juglans Regia Whole - UNII:87EJ76IO83)	Juglans Regia Whole	3 [hp_X] in 1 mL
Valerian (UNII: JWF5YAW3QW) (Valerian - UNII:JWF5YAW3QW)	Valerian	3 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Alcohol (UNII: 3K9958V90M)

#	Item Code	Package Description
Packaging
1	NDC:55714-1511-1	29.57 mL in 1 BOTTLE, GLASS
2	NDC:55714-1511-2	59.14 mL in 1 BOTTLE, GLASS
3	NDC:55714-1511-0	.5 mL in 1 BOTTLE, GLASS

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		03/01/2011

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Name	Address	ID/FEI	Business Operations
Establishment
Newton Laboratories, Inc.		788793610	MANUFACTURE(55714-1511)