INDICATIONS & USAGE SECTION

Diarrhea - Gas Formulated for associated symptoms such as loose stools, nausea, bloating, decreased appetite, fatigue, flatulence and offensive odors.

DOSAGE & ADMINISTRATION SECTION

Directions: Pets, under 50 lbs., give 3 drops by mouth (50 to 500 lbs. - 6 drops, over 500 lbs. - 1/2 teaspoon) as needed or as directed by a health professional. Place in mouth or purified water.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Aesculus hipp. 3x, Juglans regia 3x, 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, Podoph. pelt. 15x, Raphanus 15x, Tabacum 15x, Vaccinium 15x, Zingiber 15x, Pyrogenium 30x .

OTC - PURPOSE SECTION

Formulated for associated symptoms such as loose stools, nausea, bloating, decreased appetite, fatigue, flatulence and offensive odors.

INACTIVE INGREDIENT SECTION

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

QUESTIONS SECTION

newtonlabs.net Questions? 1.800.448.7256
Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

WARNINGS SECTION

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

DIARRHEA - GAS
pyrogenium, aconitum nap., arg. nit., arsenicum alb., baptisia, bryonia, carbo veg., chamomilla, cinchona, collinsonia, colocynthis, elaterium, gelsemium, ipecac., iris versicolor, lycopodium, podoph. pelt., raphanus, tabacum, vaccinium, zingiber, aesculus hipp., juglans regia liquid

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC:55714-4329
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Rancid Beef (UNII: 29SUH5R3HU) (Rancid Beef - UNII:29SUH5R3HU)	Rancid Beef	30 [hp_X] in 1 mL
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
Podophyllum (UNII: 2S713A4VP3) (Podophyllum - UNII:2S713A4VP3)	Podophyllum	15 [hp_X] in 1 mL
Radish (UNII: EM5RP35463) (Radish - UNII:EM5RP35463)	Radish	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
Ginger (UNII: C5529G5JPQ) (Ginger - UNII:C5529G5JPQ)	Ginger	15 [hp_X] in 1 mL
Horse Chestnut (UNII: 3C18L6RJAZ) (Horse Chestnut - UNII:3C18L6RJAZ)	Horse Chestnut	3 [hp_X] in 1 mL
Juglans Regia Leaf (UNII: 85HKB87105) (Juglans Regia Leaf - UNII:85HKB87105)	Juglans Regia Leaf	3 [hp_X] in 1 mL

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

#	Item Code	Package Description
Packaging
1	NDC:55714-4329-1	29.57 mL in 1 BOTTLE, GLASS
2	NDC:55714-4329-2	59.14 mL in 1 BOTTLE, GLASS
3	NDC:55714-4329-0	14.78 mL in 1 BOTTLE, GLASS

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		07/15/2011	12/31/2018

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC:55714-4281
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Rancid Beef (UNII: 29SUH5R3HU) (Rancid Beef - UNII:29SUH5R3HU)	Rancid Beef	30 [hp_X] in 1 mL
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
Podophyllum (UNII: 2S713A4VP3) (Podophyllum - UNII:2S713A4VP3)	Podophyllum	15 [hp_X] in 1 mL
Radish (UNII: EM5RP35463) (Radish - UNII:EM5RP35463)	Radish	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
Ginger (UNII: C5529G5JPQ) (Ginger - UNII:C5529G5JPQ)	Ginger	15 [hp_X] in 1 mL
Horse Chestnut (UNII: 3C18L6RJAZ) (Horse Chestnut - UNII:3C18L6RJAZ)	Horse Chestnut	6 [hp_X] in 1 mL
Juglans Regia Leaf (UNII: 85HKB87105) (Juglans Regia Leaf - UNII:85HKB87105)	Juglans Regia Leaf	6 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Alcohol (UNII: 3K9958V90M)
Water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55714-4281-1	30 mL in 1 BOTTLE, GLASS

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		01/14/2019

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Name	Address	ID/FEI	Business Operations
Establishment
Newton Laboratories, Inc.		788793610	MANUFACTURE, API MANUFACTURE