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
- NDC Code(s): 55714-4281-1, 55714-4329-0, 55714-4329-1, 55714-4329-2
- Packager: Newton Laboratories, Inc.
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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Drug Label Information
Updated January 14, 2019
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- INDICATIONS & USAGE SECTION
- DOSAGE & ADMINISTRATION SECTION
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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
- INACTIVE INGREDIENT SECTION
- QUESTIONS SECTION
- WARNINGS SECTION
- OTC - PREGNANCY OR BREAST FEEDING SECTION
- OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- PACKAGE LABEL
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INGREDIENTS AND APPEARANCE
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 liquidProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:55714-4329 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength Alcohol (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/15/2011 12/31/2018 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 liquidProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:55714-4281 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength Alcohol (UNII: 3K9958V90M) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55714-4281-1 30 mL in 1 BOTTLE, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/14/2019 Labeler - Newton Laboratories, Inc. (788793610) Registrant - Newton Laboratories, Inc. (788793610) Establishment Name Address ID/FEI Business Operations Newton Laboratories, Inc. 788793610 MANUFACTURE, API MANUFACTURE