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 pellet
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Contains inactivated NDC Code(s)
NDC Code(s): 55714-1711-0, 55714-1711-1, 55714-1711-2 - Packager: Newton Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated March 1, 2011
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- INDICATIONS & USAGE SECTION
- DOSAGE & ADMINISTRATION SECTION
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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
- INACTIVE INGREDIENT SECTION
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QUESTIONS SECTION
www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions? 1.800.448.7256 - 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
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 pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55714-1711 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Aconitum Napellus (UNII: U0NQ8555JD) (Aconitum Napellus - UNII:U0NQ8555JD) Aconitum Napellus 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 Baptisia Tinctoria (UNII: 5K1UO2888Y) (Baptisia Tinctoria - UNII:5K1UO2888Y) Baptisia Tinctoria 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 Activated Charcoal (UNII: 2P3VWU3H10) (Activated Charcoal - UNII:2P3VWU3H10) Activated Charcoal 15 [hp_X] in 1 g Matricaria Recutita (UNII: G0R4UBI2ZZ) (Matricaria Recutita - UNII:G0R4UBI2ZZ) Matricaria Recutita 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 Collinsonia Canadensis Root (UNII: O2630F3XDR) (Collinsonia Canadensis Root - UNII:O2630F3XDR) Collinsonia Canadensis Root 15 [hp_X] in 1 g Citrullus Colocynthis Fruit Pulp (UNII: 23H32AOH17) (Citrullus Colocynthis Fruit Pulp - UNII:23H32AOH17) Citrullus Colocynthis Fruit Pulp 15 [hp_X] in 1 g Ecballium Elaterium Fruit (UNII: 8P8HWT6ZWC) (Ecballium Elaterium Fruit - UNII:8P8HWT6ZWC) Ecballium Elaterium Fruit 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 Ipecac (UNII: 62I3C8233L) (Ipecac - UNII:62I3C8233L) Ipecac 15 [hp_X] in 1 g Iris Versicolor Root (UNII: X43D4L3DQC) (Iris Versicolor Root - UNII:X43D4L3DQC) Iris Versicolor Root 15 [hp_X] in 1 g Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479) Lycopodium Clavatum Spore 15 [hp_X] in 1 g Magnesium Carbonate (UNII: 0E53J927NA) (Carbonate Ion - UNII:7UJQ5OPE7D) Magnesium Carbonate 15 [hp_X] in 1 g Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus 15 [hp_X] in 1 g Podophyllum (UNII: 2S713A4VP3) (Podophyllum - UNII:2S713A4VP3) Podophyllum 15 [hp_X] in 1 g Rheum Officinale Whole (UNII: VC3KP6B2CE) (Rheum Officinale Whole - UNII:VC3KP6B2CE) Rheum Officinale Whole 15 [hp_X] in 1 g Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70) Sulfur 15 [hp_X] in 1 g Tobacco Leaf (UNII: 6YR2608RSU) (Tobacco Leaf - UNII:6YR2608RSU) Tobacco Leaf 15 [hp_X] in 1 g Bilberry (UNII: 9P2U39H18W) (Bilberry - UNII:9P2U39H18W) Bilberry 15 [hp_X] in 1 g Horse Chestnut (UNII: 3C18L6RJAZ) (Horse Chestnut - UNII:3C18L6RJAZ) Horse Chestnut 3 [hp_X] in 1 g Juglans Regia Whole (UNII: 87EJ76IO83) (Juglans Regia Whole - UNII:87EJ76IO83) Juglans Regia Whole 3 [hp_X] in 1 g Valerian (UNII: JWF5YAW3QW) (Valerian - UNII:JWF5YAW3QW) Valerian 3 [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:55714-1711-1 28.35 g in 1 BOTTLE, GLASS 2 NDC:55714-1711-2 56.7 g in 1 BOTTLE, GLASS 3 NDC:55714-1711-0 7.08 g in 1 BOTTLE, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/01/2011 Labeler - Newton Laboratories, Inc. (788793610) Registrant - Newton Laboratories, Inc. (788793610) Establishment Name Address ID/FEI Business Operations Newton Laboratories, Inc. 788793610 MANUFACTURE(55714-1711)
