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 
Newton Laboratories, Inc.

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.

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Dairy - Grain - Nightshades

INDICATIONS & USAGE SECTION

Formulated for symptoms associated with respiratory, gastro-intestinal, integumentary or vascular systems.

DOSAGE & ADMINISTRATION SECTION

Directions:   Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional. 

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

Formulated for symptoms associated with respiratory, gastro-intestinal, integumentary or vascular systems.

INACTIVE INGREDIENT SECTION

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

QUESTIONS SECTION

www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions?  1.800.448.7256

WARNINGS SECTION

Warning:   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.

package 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
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:55714-4572
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Cow Milk (UNII: 917J3173FT) (Cow Milk - UNII:917J3173FT) Cow Milk60 [hp_X]  in 1 mL
Skim Milk (UNII: 6A001Y4M5A) (Skim Milk - UNII:6A001Y4M5A) Skim Milk60 [hp_X]  in 1 mL
Cow Milk Fat (UNII: 463JZS0XJ3) (Cow Milk Fat - UNII:463JZS0XJ3) Cow Milk Fat60 [hp_X]  in 1 mL
Casein, Lactococcus Lactis Cultured, Aged (UNII: CJP9NL7JSJ) (Casein, Lactococcus Lactis Cultured, Aged - UNII:CJP9NL7JSJ) Casein, Lactococcus Lactis Cultured, Aged60 [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, Aged60 [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, Aged60 [hp_X]  in 1 mL
Barley (UNII: 5PWM7YLI7R) (Barley - UNII:5PWM7YLI7R) Barley60 [hp_X]  in 1 mL
Corn (UNII: 0N8672707O) (Corn - UNII:0N8672707O) Corn60 [hp_X]  in 1 mL
Wheat Gluten (UNII: 1534K8653J) (Wheat Gluten - UNII:1534K8653J) Wheat Gluten60 [hp_X]  in 1 mL
Oat (UNII: Z6J799EAJK) (Oat - UNII:Z6J799EAJK) Oat60 [hp_X]  in 1 mL
White Rice (UNII: A195V20H7A) (White Rice - UNII:A195V20H7A) White Rice60 [hp_X]  in 1 mL
Rye (UNII: 0R4AQI398X) (Rye - UNII:0R4AQI398X) Rye60 [hp_X]  in 1 mL
Wheat (UNII: 4J2I0SN84Y) (Wheat - UNII:4J2I0SN84Y) Wheat60 [hp_X]  in 1 mL
Atropa Belladonna (UNII: WQZ3G9PF0H) (Atropa Belladonna - UNII:WQZ3G9PF0H) Atropa Belladonna15 [hp_X]  in 1 mL
Capsicum (UNII: 00UK7646FG) (Capsicum - UNII:00UK7646FG) Capsicum15 [hp_X]  in 1 mL
Solanum Dulcamara Top (UNII: KPS1B1162N) (Solanum Dulcamara Top - UNII:KPS1B1162N) Solanum Dulcamara Top15 [hp_X]  in 1 mL
Hyoscyamus Niger (UNII: 4WRK2153H3) (Hyoscyamus Niger - UNII:4WRK2153H3) Hyoscyamus Niger15 [hp_X]  in 1 mL
Solanum Nigrum Whole (UNII: 0FMD6WV47M) (Solanum Nigrum Whole - UNII:0FMD6WV47M) Solanum Nigrum Whole15 [hp_X]  in 1 mL
Datura Stramonium (UNII: G6W4F0V8Z3) (Datura Stramonium - UNII:G6W4F0V8Z3) Datura Stramonium15 [hp_X]  in 1 mL
Tobacco Leaf (UNII: 6YR2608RSU) (Tobacco Leaf - UNII:6YR2608RSU) Tobacco Leaf15 [hp_X]  in 1 mL
Solanum Lycopersicum (UNII: 0243Q4990L) (Solanum Lycopersicum - UNII:0243Q4990L) Solanum Lycopersicum15 [hp_X]  in 1 mL
Lactose (UNII: J2B2A4N98G) (Anhydrous Lactose - UNII:3SY5LH9PMK) Lactose15 [hp_X]  in 1 mL
Solanum Tuberosum (UNII: 2A8I57T4MX) (Solanum Tuberosum - UNII:2A8I57T4MX) Solanum Tuberosum15 [hp_X]  in 1 mL
Saccharomyces Cerevisiae (UNII: 978D8U419H) (Saccharomyces Cerevisiae - UNII:978D8U419H) Saccharomyces Cerevisiae15 [hp_X]  in 1 mL
Ustilago Maydis (UNII: 4K7Z7K7SWG) (Ustilago Maydis - UNII:4K7Z7K7SWG) Ustilago Maydis15 [hp_X]  in 1 mL
Antimony Trisulfide (UNII: F79059A38U) (Antimony Cation (3+) - UNII:069647RPT5) Antimony Trisulfide10 [hp_X]  in 1 mL
Silver Nitrate (UNII: 95IT3W8JZE) (Silver Cation - UNII:57N7B0K90A) Silver Nitrate10 [hp_X]  in 1 mL
Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Trioxide10 [hp_X]  in 1 mL
Baptisia Tinctoria Root (UNII: 5EF0HWI5WU) (Baptisia Tinctoria Root - UNII:5EF0HWI5WU) Baptisia Tinctoria Root10 [hp_X]  in 1 mL
Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root10 [hp_X]  in 1 mL
Centaurea Benedicta (UNII: 6L5ZL09795) (Centaurea Benedicta - UNII:6L5ZL09795) Centaurea Benedicta10 [hp_X]  in 1 mL
Cinchona Officinalis Bark (UNII: S003A158SB) (Cinchona Officinalis Bark - UNII:S003A158SB) Cinchona Officinalis Bark10 [hp_X]  in 1 mL
Gelsemium Sempervirens Root (UNII: 639KR60Q1Q) (Gelsemium Sempervirens Root - UNII:639KR60Q1Q) Gelsemium Sempervirens Root10 [hp_X]  in 1 mL
Ipecac (UNII: 62I3C8233L) (Ipecac - UNII:62I3C8233L) Ipecac10 [hp_X]  in 1 mL
Lachesis Muta Venom (UNII: VSW71SS07I) (Lachesis Muta Venom - UNII:VSW71SS07I) Lachesis Muta Venom10 [hp_X]  in 1 mL
Sodium Chloride (UNII: 451W47IQ8X) (Chloride Ion - UNII:Q32ZN48698) Sodium Chloride10 [hp_X]  in 1 mL
Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus10 [hp_X]  in 1 mL
Podophyllum (UNII: 2S713A4VP3) (Podophyllum - UNII:2S713A4VP3) Podophyllum10 [hp_X]  in 1 mL
Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV) Pulsatilla Vulgaris10 [hp_X]  in 1 mL
Toxicodendron Pubescens Leaf (UNII: 6IO182RP7A) (Toxicodendron Pubescens Leaf - UNII:6IO182RP7A) Toxicodendron Pubescens Leaf10 [hp_X]  in 1 mL
Sepia Officinalis Juice (UNII: QDL83WN8C2) (Sepia Officinalis Juice - UNII:QDL83WN8C2) Sepia Officinalis Juice10 [hp_X]  in 1 mL
Elymus Repens Root (UNII: 3IXW0F6P8W) (Elymus Repens Root - UNII:3IXW0F6P8W) Elymus Repens Root10 [hp_X]  in 1 mL
Verbascum Thapsus (UNII: C9TD27U172) (Verbascum Thapsus - UNII:C9TD27U172) Verbascum Thapsus10 [hp_X]  in 1 mL
Iris Versicolor Root (UNII: X43D4L3DQC) (Iris Versicolor Root - UNII:X43D4L3DQC) Iris Versicolor Root3 [hp_X]  in 1 mL
Solidago Virgaurea Flowering Top (UNII: 5405K23S50) (Solidago Virgaurea Flowering Top - UNII:5405K23S50) Solidago Virgaurea Flowering Top3 [hp_X]  in 1 mL
Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479) Lycopodium Clavatum Spore10 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Alcohol (UNII: 3K9958V90M)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55714-4572-130 mL in 1 BOTTLE, GLASS
2NDC:55714-4572-259 mL in 1 BOTTLE, GLASS
3NDC:55714-4572-015 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/01/2011
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610MANUFACTURE(55714-4572)

Revised: 6/2011
Document Id: d91ed19d-70e9-8c6c-75de-21bacde569a2
Set id: d11432b4-74a0-7de5-dde2-973896201931
Version: 1
Effective Time: 20110601
 
Newton Laboratories, Inc.