Label: DAIRY - GRAIN - NIGHTSHADES- cow milk, skim milk, cow milk fat, casein lactococcus lactis cultured aged, casein lactococcus lactis cultured penicilium roqueforti cultured aged, casein lctococcus lactis cultured penicillium camemberti cultured aged, barley, corn, wheat gluten, oat, white rice, rye, wheat, lycopersicum esculentum, sac. lac., solanum tuberosum,torula cerevisiae, ustilago maidis, antimon. crud., arg.nit., arsenicum alb., baptisia, bryonia, carduus benedictus, cinchona, gelsemium, ipecac., lachesis, lycopodium liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 55714-2312-0, 55714-2312-1, 55714-2312-2 - 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
Allersodes 60x, Allersodes 15x , Lycopersicum 15x, Sac. lac. 15x, Solanum tub. 15x, Torula cerevisiae 15x, Ustilago maidis 15x, Antimon. crud. 10x, Arg. nit. 10x, Arsenicum alb. 10x, Baptisia 10x, Bryonia 10x, Carduus ben. 10x, Cinchona 10x, Gelsemium 10x, Ipecac. 10x, Lachesis 10x, Lycopodium 10x, Nat. mur. 10x, Phos. 10x, Podoph. pelt.10x, Pulsatilla 10x, Rhus tox. 10x, Sepia 10x, Triticum 10x, Verbascum 10x, Iris vers. 3x, Solidago 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
DAIRY - GRAIN - NIGHTSHADES
cow milk, skim milk, cow milk fat, casein lactococcus lactis cultured aged, casein lactococcus lactis cultured penicilium roqueforti cultured aged, casein lctococcus lactis cultured penicillium camemberti cultured aged, barley, corn, wheat gluten, oat, white rice, rye, wheat, lycopersicum esculentum, sac. lac., solanum tuberosum,torula cerevisiae, ustilago maidis, antimon. crud., arg.nit., arsenicum alb., baptisia, bryonia, carduus benedictus, cinchona, gelsemium, ipecac., lachesis, lycopodium liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55714-2312 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Cow Milk (UNII: 917J3173FT) (Cow Milk - UNII:917J3173FT) Cow Milk 60 [hp_X] in 1 mL Skim Milk (UNII: 6A001Y4M5A) (Skim Milk - UNII:6A001Y4M5A) Skim Milk 60 [hp_X] in 1 mL Cow Milk Fat (UNII: 463JZS0XJ3) (Cow Milk Fat - UNII:463JZS0XJ3) Cow Milk Fat 60 [hp_X] in 1 mL Casein, Lactococcus Lactis Cultured, Aged (UNII: CJP9NL7JSJ) (Casein, Lactococcus Lactis Cultured, Aged - UNII:CJP9NL7JSJ) Casein, Lactococcus Lactis Cultured, Aged 60 [hp_X] in 1 mL Casein, Lactococcus Lactis Cultured, Penicillium Roqueforti Cultured, Aged (UNII: IYI0G2057S) (Casein, Lactococcus Lactis Cultured, Penicillium Roqueforti Cultured, Aged - UNII:IYI0G2057S) Casein, Lactococcus Lactis Cultured, Penicillium Roqueforti Cultured, Aged 60 [hp_X] in 1 mL Casein, Lactococcus Lactis Cultured, Penicillium Camemberti Cultured, Aged (UNII: G44KTI7KIS) (Casein, Lactococcus Lactis Cultured, Penicillium Camemberti Cultured, Aged - UNII:G44KTI7KIS) Casein, Lactococcus Lactis Cultured, Penicillium Camemberti Cultured, Aged 60 [hp_X] in 1 mL Barley (UNII: 5PWM7YLI7R) (Barley - UNII:5PWM7YLI7R) Barley 60 [hp_X] in 1 mL Corn (UNII: 0N8672707O) (Corn - UNII:0N8672707O) Corn 60 [hp_X] in 1 mL Wheat Gluten (UNII: 1534K8653J) (Wheat Gluten - UNII:1534K8653J) Wheat Gluten 60 [hp_X] in 1 mL Oat (UNII: Z6J799EAJK) (Oat - UNII:Z6J799EAJK) Oat 60 [hp_X] in 1 mL White Rice (UNII: A195V20H7A) (White Rice - UNII:A195V20H7A) White Rice 60 [hp_X] in 1 mL Rye (UNII: 0R4AQI398X) (Rye - UNII:0R4AQI398X) Rye 60 [hp_X] in 1 mL Wheat (UNII: 4J2I0SN84Y) (Wheat - UNII:4J2I0SN84Y) Wheat 60 [hp_X] in 1 mL Atropa Belladonna (UNII: WQZ3G9PF0H) (Atropa Belladonna - UNII:WQZ3G9PF0H) Atropa Belladonna 15 [hp_X] in 1 mL Capsicum (UNII: 00UK7646FG) (Capsicum - UNII:00UK7646FG) Capsicum 15 [hp_X] in 1 mL Solanum Dulcamara Top (UNII: KPS1B1162N) (Solanum Dulcamara Top - UNII:KPS1B1162N) Solanum Dulcamara Top 15 [hp_X] in 1 mL Hyoscyamus Niger (UNII: 4WRK2153H3) (Hyoscyamus Niger - UNII:4WRK2153H3) Hyoscyamus Niger 15 [hp_X] in 1 mL Solanum Nigrum Whole (UNII: 0FMD6WV47M) (Solanum Nigrum Whole - UNII:0FMD6WV47M) Solanum Nigrum Whole 15 [hp_X] in 1 mL Datura Stramonium (UNII: G6W4F0V8Z3) (Datura Stramonium - UNII:G6W4F0V8Z3) Datura Stramonium 15 [hp_X] in 1 mL Tobacco Leaf (UNII: 6YR2608RSU) (Tobacco Leaf - UNII:6YR2608RSU) Tobacco Leaf 15 [hp_X] in 1 mL Solanum Lycopersicum (UNII: 0243Q4990L) (Solanum Lycopersicum - UNII:0243Q4990L) Solanum Lycopersicum 15 [hp_X] in 1 mL Lactose (UNII: J2B2A4N98G) (Anhydrous Lactose - UNII:3SY5LH9PMK) Lactose 15 [hp_X] in 1 mL Solanum Tuberosum (UNII: 2A8I57T4MX) (Solanum Tuberosum - UNII:2A8I57T4MX) Solanum Tuberosum 15 [hp_X] in 1 mL Saccharomyces Cerevisiae (UNII: 978D8U419H) (Saccharomyces Cerevisiae - UNII:978D8U419H) Saccharomyces Cerevisiae 15 [hp_X] in 1 mL Ustilago Maydis (UNII: 4K7Z7K7SWG) (Ustilago Maydis - UNII:4K7Z7K7SWG) Ustilago Maydis 15 [hp_X] in 1 mL Antimony Trisulfide (UNII: F79059A38U) (Antimony Cation (3+) - UNII:069647RPT5) Antimony Trisulfide 10 [hp_X] in 1 mL Silver Nitrate (UNII: 95IT3W8JZE) (Silver Cation - UNII:57N7B0K90A) Silver Nitrate 10 [hp_X] in 1 mL Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Trioxide 10 [hp_X] in 1 mL Baptisia Tinctoria Root (UNII: 5EF0HWI5WU) (Baptisia Tinctoria Root - UNII:5EF0HWI5WU) Baptisia Tinctoria Root 10 [hp_X] in 1 mL Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root 10 [hp_X] in 1 mL Centaurea Benedicta (UNII: 6L5ZL09795) (Centaurea Benedicta - UNII:6L5ZL09795) Centaurea Benedicta 10 [hp_X] in 1 mL Cinchona Officinalis Bark (UNII: S003A158SB) (Cinchona Officinalis Bark - UNII:S003A158SB) Cinchona Officinalis Bark 10 [hp_X] in 1 mL Gelsemium Sempervirens Root (UNII: 639KR60Q1Q) (Gelsemium Sempervirens Root - UNII:639KR60Q1Q) Gelsemium Sempervirens Root 10 [hp_X] in 1 mL Ipecac (UNII: 62I3C8233L) (Ipecac - UNII:62I3C8233L) Ipecac 10 [hp_X] in 1 mL Lachesis Muta Venom (UNII: VSW71SS07I) (Lachesis Muta Venom - UNII:VSW71SS07I) Lachesis Muta Venom 10 [hp_X] in 1 mL Sodium Chloride (UNII: 451W47IQ8X) (Chloride Ion - UNII:Q32ZN48698) Sodium Chloride 10 [hp_X] in 1 mL Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus 10 [hp_X] in 1 mL Podophyllum (UNII: 2S713A4VP3) (Podophyllum - UNII:2S713A4VP3) Podophyllum 10 [hp_X] in 1 mL Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV) Pulsatilla Vulgaris 10 [hp_X] in 1 mL Toxicodendron Pubescens Leaf (UNII: 6IO182RP7A) (Toxicodendron Pubescens Leaf - UNII:6IO182RP7A) Toxicodendron Pubescens Leaf 10 [hp_X] in 1 mL Sepia Officinalis Juice (UNII: QDL83WN8C2) (Sepia Officinalis Juice - UNII:QDL83WN8C2) Sepia Officinalis Juice 10 [hp_X] in 1 mL Elymus Repens Root (UNII: 3IXW0F6P8W) (Elymus Repens Root - UNII:3IXW0F6P8W) Elymus Repens Root 10 [hp_X] in 1 mL Verbascum Thapsus (UNII: C9TD27U172) (Verbascum Thapsus - UNII:C9TD27U172) Verbascum Thapsus 10 [hp_X] in 1 mL Iris Versicolor Root (UNII: X43D4L3DQC) (Iris Versicolor Root - UNII:X43D4L3DQC) Iris Versicolor Root 3 [hp_X] in 1 mL Solidago Virgaurea Flowering Top (UNII: 5405K23S50) (Solidago Virgaurea Flowering Top - UNII:5405K23S50) Solidago Virgaurea Flowering Top 3 [hp_X] in 1 mL Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479) Lycopodium Clavatum Spore 10 [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:55714-2312-1 30 mL in 1 BOTTLE, GLASS 2 NDC:55714-2312-2 59 mL in 1 BOTTLE, GLASS 3 NDC:55714-2312-0 15 mL 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(55714-2312)