Label: DIARRHEA- aesculus hippocastanum, juglans regia, valeriana officinalis, aconitum napellus, argentum nitricum, arsenicum album, baptisia tinctoria, bryonia, carbo vegetabilis, chamomilla, cinchona officinalis, collinsonia canadensis, colocynthis, elaterium, gelsemium sempervirens, ipecacuanha, iris versicolor, lycopodium clavatum, magnesia carbonica, phosphorus, podophyllum peltatum, rheum, sulphur, tabacum, vaccinium myrtillus liquid
- NDC Code(s): 55714-1525-1
- 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 January 31, 2020
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- INDICATIONS AND USAGE SECTION
- DOSAGE & ADMINISTRATION SECTION
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OTC - ACTIVE INGREDIENT SECTION
Equal parts of Aesculus hippocastanum 6x, Juglans regia 6x, Valeriana officinalis 6x, Aconitum napellus 15x, Argentum nitricum 15x, Arsenicum album 15x, Baptisia tinctoria 15x, Bryonia 15x, Carbo vegetabilis 15x, Chamomilla 15x, Cinchona officinalis 15x, Collinsonia canadensis 15x, Colocynthis 15x, Elaterium 15x, Gelsemium sempervirens 15x, Ipecacuanha 15x, Iris versicolor 15x, Lycopodium clavatum 15x, Magnesia carbonica 15x, Phosphorus 15x, Podophyllum peltatum 15x, Rheum 15x, Sulphur 15x, Tabacum 15x, Vaccinium myrtillus 15x.
- 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
aesculus hippocastanum, juglans regia, valeriana officinalis, aconitum napellus, argentum nitricum, arsenicum album, baptisia tinctoria, bryonia, carbo vegetabilis, chamomilla, cinchona officinalis, collinsonia canadensis, colocynthis, elaterium, gelsemium sempervirens, ipecacuanha, iris versicolor, lycopodium clavatum, magnesia carbonica, phosphorus, podophyllum peltatum, rheum, sulphur, tabacum, vaccinium myrtillus liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55714-1525 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ) HORSE CHESTNUT 6 [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 VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN 6 [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 ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU) BAPTISIA TINCTORIA ROOT 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 CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA 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 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 ROOT (UNII: A47JP5ZG9M) (RHEUM OFFICINALE ROOT - UNII:A47JP5ZG9M) RHEUM OFFICINALE ROOT 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 ECBALLIUM ELATERIUM FRUIT (UNII: 8P8HWT6ZWC) (ECBALLIUM ELATERIUM FRUIT - UNII:8P8HWT6ZWC) ECBALLIUM ELATERIUM FRUIT 15 [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 WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55714-1525-1 30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 01/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/01/2019 Labeler - Newton Laboratories, Inc. (788793610) Registrant - Newton Laboratories, Inc. (788793610) Establishment Name Address ID/FEI Business Operations Newton Laboratories, Inc. 788793610 manufacture(55714-1525)
