Label: DAIRY-GRAIN-NIGHTSHADES- iris vers., solidago, antimon. crud., arg. nit., arsenicum alb., avena, baptisia, belladonna, bryonia, capsicum, carduus ben., cinchona, dulcamara, fagopyrum, gelsemium, hyoscyamus, ipecac., lac vac., lachesis, lycopodium, nat. mur., phos., podoph. pelt., pulsatilla, rhus tox., sac. lac., secale, sepia, stramonium, tabacum, triticum, ustilago maidis, verbascum, lycopersicum, solanum nig., solanum tub., stigmata, torula cerevisiae. liquid

  • NDC Code(s): 55714-2416-1
  • 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 8, 2020

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  • INDICATIONS & USAGE SECTION

    Formulated for symptoms associated with sensitivity and intolerance to dairy, grain and nightshade foods.

  • 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. Sensitive persons begin with 1 drop and gradually increase to full dose.

  • OTC - ACTIVE INGREDIENT SECTION

    Equal parts of Iris versicolor 6x, Solidago virgaurea 6x, Antimonium crudum 15x, Argentum nitricum 15x, Arsenicum album 15x, Avena sativa 15x, Baptisia tinctoria 15x, Belladonna 15x, Bryonia 15x, Capsicum annuum 15x, Carduus benedictus 15x, Cinchona officinalis 15x, Dulcamara 15x, Fagopyrum esculentum 15x, Gelsemium sempervirens 15x, Hyoscyamus niger 15x, Ipecacuanha 15x, Lac vaccinum 15x, Lachesis mutus 15x, Lycopodium clavatum 15x, Natrum muriaticum 15x, Phosphorus 15x, Podophyllum peltatum 15x, Pulsatilla 15x, Rhus toxicodendron 15x, Saccharum lactis 15x, Secale cornutum 15x, Sepia 15x, Stramonium 15x, Tabacum 15x, Triticum repens 15x, Ustilago maidis 15x, Verbascum thapsus 15x, Lycopersicum esculentum 16x, Solanum nigrum 16x, Solanum tuberosum 16x, Stigmata maidis 16x, Torula cerevisiae 16x.

  • OTC - PURPOSE SECTION

    Formulated for symptoms associated with sensitivity and intolerance to dairy, grain and nightshade foods.

  • INACTIVE INGREDIENT SECTION

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

  • QUESTIONS SECTION

    newtonlabs.net - Questions? 800.448.7256

    Newton Laboratories, Inc. FDA Est # 1051203 Conyers, GA 30013

  • WARNINGS SECTION

    WARNINGS: 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

  • INGREDIENTS AND APPEARANCE
    DAIRY-GRAIN-NIGHTSHADES 
    iris vers., solidago, antimon. crud., arg. nit., arsenicum alb., avena, baptisia, belladonna, bryonia, capsicum, carduus ben., cinchona, dulcamara, fagopyrum, gelsemium, hyoscyamus, ipecac., lac vac., lachesis, lycopodium, nat. mur., phos., podoph. pelt., pulsatilla, rhus tox., sac. lac., secale, sepia, stramonium, tabacum, triticum, ustilago maidis, verbascum, lycopersicum, solanum nig., solanum tub., stigmata, torula cerevisiae. liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-2416
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CORN SILK (UNII: 7D3VB244UX) (CORN SILK - UNII:7D3VB244UX) CORN SILK16 [hp_X]  in 1 mL
    COW MILK (UNII: 917J3173FT) (COW MILK - UNII:917J3173FT) COW MILK15 [hp_X]  in 1 mL
    SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50) SOLIDAGO VIRGAUREA FLOWERING TOP6 [hp_X]  in 1 mL
    SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE15 [hp_X]  in 1 mL
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA15 [hp_X]  in 1 mL
    TOBACCO LEAF (UNII: 6YR2608RSU) (TOBACCO LEAF - UNII:6YR2608RSU) TOBACCO LEAF15 [hp_X]  in 1 mL
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE15 [hp_X]  in 1 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS15 [hp_X]  in 1 mL
    BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU) BAPTISIA TINCTORIA ROOT15 [hp_X]  in 1 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE15 [hp_X]  in 1 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE15 [hp_X]  in 1 mL
    ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA15 [hp_X]  in 1 mL
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) (ANHYDROUS LACTOSE - UNII:3SY5LH9PMK) LACTOSE, UNSPECIFIED FORM15 [hp_X]  in 1 mL
    PODOPHYLLUM (UNII: 2S713A4VP3) (PODOPHYLLUM - UNII:2S713A4VP3) PODOPHYLLUM15 [hp_X]  in 1 mL
    VERBASCUM THAPSUS (UNII: C9TD27U172) (VERBASCUM THAPSUS - UNII:C9TD27U172) VERBASCUM THAPSUS15 [hp_X]  in 1 mL
    SOLANUM NIGRUM WHOLE (UNII: 0FMD6WV47M) (SOLANUM NIGRUM WHOLE - UNII:0FMD6WV47M) SOLANUM NIGRUM WHOLE16 [hp_X]  in 1 mL
    IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC) IRIS VERSICOLOR ROOT6 [hp_X]  in 1 mL
    AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP15 [hp_X]  in 1 mL
    CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM15 [hp_X]  in 1 mL
    CENTAUREA BENEDICTA (UNII: 6L5ZL09795) (CENTAUREA BENEDICTA - UNII:6L5ZL09795) CENTAUREA BENEDICTA15 [hp_X]  in 1 mL
    CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK15 [hp_X]  in 1 mL
    ANTIMONY TRISULFIDE (UNII: F79059A38U) (ANTIMONY TRISULFIDE - UNII:F79059A38U) ANTIMONY TRISULFIDE15 [hp_X]  in 1 mL
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF15 [hp_X]  in 1 mL
    HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER15 [hp_X]  in 1 mL
    IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC15 [hp_X]  in 1 mL
    ELYMUS REPENS ROOT (UNII: 3IXW0F6P8W) (ELYMUS REPENS ROOT - UNII:3IXW0F6P8W) ELYMUS REPENS ROOT15 [hp_X]  in 1 mL
    LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM15 [hp_X]  in 1 mL
    SOLANUM DULCAMARA TOP (UNII: KPS1B1162N) (SOLANUM DULCAMARA TOP - UNII:KPS1B1162N) SOLANUM DULCAMARA TOP15 [hp_X]  in 1 mL
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT15 [hp_X]  in 1 mL
    FAGOPYRUM ESCULENTUM (UNII: B10M69172N) (FAGOPYRUM ESCULENTUM - UNII:B10M69172N) FAGOPYRUM ESCULENTUM15 [hp_X]  in 1 mL
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT15 [hp_X]  in 1 mL
    DATURA STRAMONIUM (UNII: G6W4F0V8Z3) (DATURA STRAMONIUM - UNII:G6W4F0V8Z3) DATURA STRAMONIUM15 [hp_X]  in 1 mL
    USTILAGO MAYDIS (UNII: 4K7Z7K7SWG) (USTILAGO MAYDIS - UNII:4K7Z7K7SWG) USTILAGO MAYDIS15 [hp_X]  in 1 mL
    SOLANUM LYCOPERSICUM (UNII: 0243Q4990L) (SOLANUM LYCOPERSICUM - UNII:0243Q4990L) SOLANUM LYCOPERSICUM16 [hp_X]  in 1 mL
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE15 [hp_X]  in 1 mL
    SOLANUM TUBEROSUM (UNII: 2A8I57T4MX) (SOLANUM TUBEROSUM - UNII:2A8I57T4MX) SOLANUM TUBEROSUM16 [hp_X]  in 1 mL
    SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H) (SACCHAROMYCES CEREVISIAE - UNII:978D8U419H) SACCHAROMYCES CEREVISIAE16 [hp_X]  in 1 mL
    CLAVICEPS PURPUREA SCLEROTIUM (UNII: 01G9XEA93N) (CLAVICEPS PURPUREA SCLEROTIUM - UNII:01G9XEA93N) CLAVICEPS PURPUREA SCLEROTIUM15 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-2416-130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product01/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/01/2019
    Labeler - Newton Laboratories, Inc. (788793610)
    Registrant - Newton Laboratories, Inc. (788793610)
    Establishment
    NameAddressID/FEIBusiness Operations
    Newton Laboratories, Inc.788793610manufacture(55714-2416)
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