Label: GASTRITIS - ULCER- antimon. crud., arg. nit., arsenicum alb., baptisia, bismuthum metallicum, bryonia, cinchona, colocynthis, graphites, hepar sulph. calc., hydrastis, ipecac., kali bic., kali carb., lycopodium, mag. carb. mag. phos., nux vom., phosphorus, podoph. pelt., pulsatilla, zingiber, chamomilla, echinacea, iris versicolor, ruta,taraxacum liquid

  • Category: HUMAN PRESCRIPTION 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 June 1, 2011

If you are a consumer or patient please visit this version.

  • INDICATIONS & USAGE SECTION

    Gastritis - Ulcer  Formulated for symptoms associated with gastritis and duodenal, esophageal or stomach ulcers.

  • DOSAGE & ADMINISTRATION SECTION

    Directions:  ORAL USE ONLY - SHAKE WELL.  Ages 12 and up, take 6 drops orally one to four times daily or as directed by a healthcare professional.

  • ACTIVE INGREDIENT SECTION

    Antimon. crud. 15x, Arg. nit. 15x, Arsenicum alb. 15x, Baptisia 15x, Bismuthum metallicum 15x, Bryonia 15x, Cinchona 15x, Colocynthis 15x, Graphites 15x, Hepar sulph. calc. 15x, Hydrastis 15x, Ipecac. 15x, Kali bic. 15x, Kali carb.15x, Lycopodium 15x, Mag. carb. 15x, Mag. phos. 15x, Nux vom.15x, Phosphorus 15x, Podoph. pelt. 15x, Pulsatilla 15x, Zingiber 15x, Chamomilla 3x, Echinacea 3x, Iris versicolor 3x, Ruta 3x, Taraxacum 3x.

  • PURPOSE SECTION

    Formulated for symptoms associated with gastritis and duodenal, esophageal or stomach ulcers.

  • 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:  Do not use if tamper - evident seal is broken or missing.  Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days.  Keep out of reach of children.   

  • PREGNANCY OR BREAST FEEDING SECTION

    Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. 

  • KEEP OUT OF REACH OF CHILDREN SECTION

    Keep out of reach of children.

  • PACKAGE LABEL

    Package Label

  • INGREDIENTS AND APPEARANCE
    GASTRITIS - ULCER  
    antimon. crud., arg. nit., arsenicum alb., baptisia, bismuthum metallicum, bryonia, cinchona, colocynthis, graphites, hepar sulph. calc., hydrastis, ipecac., kali bic., kali carb., lycopodium, mag. carb. mag. phos., nux vom., phosphorus, podoph. pelt., pulsatilla, zingiber, chamomilla, echinacea, iris versicolor, ruta,taraxacum liquid
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:55714-4530
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Antimony Trisulfide (UNII: F79059A38U) (Antimony Trisulfide - UNII:F79059A38U) Antimony Trisulfide15 [hp_X]  in 1 mL
    Silver Nitrate (UNII: 95IT3W8JZE) (Silver Cation - UNII:57N7B0K90A) Silver Nitrate15 [hp_X]  in 1 mL
    Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Trioxide15 [hp_X]  in 1 mL
    Baptisia Tinctoria (UNII: 5K1UO2888Y) (Baptisia Tinctoria - UNII:5K1UO2888Y) Baptisia Tinctoria15 [hp_X]  in 1 mL
    Bismuth (UNII: U015TT5I8H) (Bismuth - UNII:U015TT5I8H) Bismuth15 [hp_X]  in 1 mL
    Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root15 [hp_X]  in 1 mL
    Cinchona Officinalis Bark (UNII: S003A158SB) (Cinchona Officinalis Bark - UNII:S003A158SB) Cinchona Officinalis Bark15 [hp_X]  in 1 mL
    Citrullus Colocynthis Fruit Pulp (UNII: 23H32AOH17) (Citrullus Colocynthis Fruit Pulp - UNII:23H32AOH17) Citrullus Colocynthis Fruit Pulp15 [hp_X]  in 1 mL
    Graphite (UNII: 4QQN74LH4O) (Graphite - UNII:4QQN74LH4O) Graphite15 [hp_X]  in 1 mL
    Calcium Sulfide (UNII: 1MBW07J51Q) (Calcium Sulfide - UNII:1MBW07J51Q) Calcium Sulfide15 [hp_X]  in 1 mL
    Goldenseal (UNII: ZW3Z11D0JV) (Goldenseal - UNII:ZW3Z11D0JV) Goldenseal15 [hp_X]  in 1 mL
    Ipecac (UNII: 62I3C8233L) (Ipecac - UNII:62I3C8233L) Ipecac15 [hp_X]  in 1 mL
    Potassium Dichromate (UNII: T4423S18FM) (Dichromate Ion - UNII:9LKY4BFN2V) Potassium Dichromate15 [hp_X]  in 1 mL
    Potassium Carbonate (UNII: BQN1B9B9HA) (Carbonate Ion - UNII:7UJQ5OPE7D) Potassium Carbonate15 [hp_X]  in 1 mL
    Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479) Lycopodium Clavatum Spore15 [hp_X]  in 1 mL
    Magnesium Carbonate (UNII: 0E53J927NA) (Carbonate Ion - UNII:7UJQ5OPE7D) Magnesium Carbonate15 [hp_X]  in 1 mL
    Magnesium Phosphate, Dibasic Trihydrate (UNII: HF539G9L3Q) (Magnesium Cation - UNII:T6V3LHY838) Magnesium Phosphate, Dibasic Trihydrate15 [hp_X]  in 1 mL
    Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed15 [hp_X]  in 1 mL
    Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus15 [hp_X]  in 1 mL
    Podophyllum (UNII: 2S713A4VP3) (Podophyllum - UNII:2S713A4VP3) Podophyllum15 [hp_X]  in 1 mL
    Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV) Pulsatilla Vulgaris15 [hp_X]  in 1 mL
    Ginger (UNII: C5529G5JPQ) (Ginger - UNII:C5529G5JPQ) Ginger15 [hp_X]  in 1 mL
    Matricaria Recutita (UNII: G0R4UBI2ZZ) (Matricaria Recutita - UNII:G0R4UBI2ZZ) Matricaria Recutita3 [hp_X]  in 1 mL
    Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified3 [hp_X]  in 1 mL
    Iris Versicolor Root (UNII: X43D4L3DQC) (Iris Versicolor Root - UNII:X43D4L3DQC) Iris Versicolor Root3 [hp_X]  in 1 mL
    Ruta Graveolens Flowering Top (UNII: N94C2U587S) (Ruta Graveolens Flowering Top - UNII:N94C2U587S) Ruta Graveolens Flowering Top3 [hp_X]  in 1 mL
    Taraxacum Officinale (UNII: 39981FM375) (Taraxacum Officinale - UNII:39981FM375) Taraxacum Officinale3 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Alcohol (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-4530-129.57 mL in 1 BOTTLE, GLASS
    2NDC:55714-4530-259.14 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(55714-4530)