Label: NAUSEA- bismuthum metallicum, bryonia, cimicifuga, gossypium herbaceum, ipecac., kreosotum, lycopodium, mag. carb., nux vom., pulsatilla, sepia, symphoricarpus racemosus, tabacum, zingiber, chamomilla, hydrastis, iris versicolor liquid

  • 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 April 15, 2014

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  • INDICATIONS & USAGE SECTION

    Nausea   Formulated for symptoms associated with nausea such as dizziness, discomfort, indigestion, vomiting and loss of appetite.

  • DOSAGE & ADMINISTRATION SECTION

    Directions: ORAL USE ONLY -  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) as needed or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

  • OTC - ACTIVE INGREDIENT SECTION

    Bismuthum met. 15x, Bryonia 15x, Cimicifuga 15x, Gossypium 15x, Ipecac. 15x, Kreosotum 15x, Lycopodium 15x, Mag. carb. 15x, Nux vom. 15x, Pulsatilla 15x, Sepia 15x, Symphoricarpus 15x, Tabacum 15x, Zingiber 15x, Chamomilla 3x, Hydrastis 3x, Iris vers. 3x.

  • OTC - PURPOSE SECTION

    Formulated for symptoms associated with nausea such as dizziness, discomfort, indigestion, vomiting and loss of appetite.

  • 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.

  • OTC - 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. 

  • OTC - KEEP OUT OF REACH OF CHILDREN SECTION

    Keep out of reach of children.

  • PACKAGE LABEL

    package label

  • INGREDIENTS AND APPEARANCE
    NAUSEA  
    bismuthum metallicum, bryonia, cimicifuga, gossypium herbaceum, ipecac., kreosotum, lycopodium, mag. carb., nux vom., pulsatilla, sepia, symphoricarpus racemosus, tabacum, zingiber, chamomilla, hydrastis, iris versicolor liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-8002
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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
    Black Cohosh (UNII: K73E24S6X9) (Black Cohosh - UNII:K73E24S6X9) Black Cohosh15 [hp_X]  in 1 mL
    Gossypium Herbaceum Root Bark (UNII: VQN1631P4C) (Gossypium Herbaceum Root Bark - UNII:VQN1631P4C) Gossypium Herbaceum Root Bark15 [hp_X]  in 1 mL
    Ipecac (UNII: 62I3C8233L) (Ipecac - UNII:62I3C8233L) Ipecac15 [hp_X]  in 1 mL
    Wood Creosote (UNII: 3JYG22FD73) (Wood Creosote - UNII:3JYG22FD73) Wood Creosote15 [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
    Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed15 [hp_X]  in 1 mL
    Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV) Pulsatilla Vulgaris15 [hp_X]  in 1 mL
    Sepia Officinalis Juice (UNII: QDL83WN8C2) (Sepia Officinalis Juice - UNII:QDL83WN8C2) Sepia Officinalis Juice15 [hp_X]  in 1 mL
    Symphoricarpos Albus Fruit (UNII: 873JZU3ASZ) (Symphoricarpos Albus Fruit - UNII:873JZU3ASZ) Symphoricarpos Albus Fruit15 [hp_X]  in 1 mL
    Tobacco Leaf (UNII: 6YR2608RSU) (Tobacco Leaf - UNII:6YR2608RSU) Tobacco Leaf15 [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
    Goldenseal (UNII: ZW3Z11D0JV) (Goldenseal - UNII:ZW3Z11D0JV) Goldenseal3 [hp_X]  in 1 mL
    Iris Versicolor Root (UNII: X43D4L3DQC) (Iris Versicolor Root - UNII:X43D4L3DQC) Iris Versicolor Root3 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Alcohol (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-8002-129.57 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/15/2014
    Labeler - Newton Laboratories, Inc. (788793610)
    Registrant - Newton Laboratories, Inc. (788793610)
    Establishment
    NameAddressID/FEIBusiness Operations
    Newton Laboratories, Inc.788793610MANUFACTURE(55714-8002)
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