Label: ALLERGYEASE SHELLFISH AND SEAFOOD- adrenalinum, belladona, bromium, carbo animalis, colchicum autumnale, colocynthis, histaminum hydrochloricum, hydrstis canadensis, kali carbonicum, lycopodium clavatum, mercuris solubilis, pulsatilla, urtica urens spray

  • 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 June 13, 2013

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  • PURPOSE

    Relieves mild irritation caused by shellfish and seafood

  • ACTIVE INGREDIENT

    Drug Facts
    Active Ingredients:     Adrenalinum, Belladona, Bromium, Carbo animalis, Colchicum autumnale, Colocynthis, Histaminum hydrochloricum, Hydrstis canadensis, Kali carbonicum, Lycopodium clavatum, Mercuris solubilis, Pulsatilla, Urtica urens

  • INDICATIONS & USAGE

    Uses:For temporary relief of symptoms from shellfish and seafood: indigestions, diarrhea, nausea, sinus congestion, headaches, skin irritations, and abdominal cramps

  • WARNINGS

    Warnings: Stop use and ask a doctor if symptoms persist or worsen

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a health professional before use

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all medications out of reach of children

  • OVERDOSAGE

    In case of overdose, get medical help or contact a Poison Control Center right away. NOTE: For severe allergy symptoms consult your physician. NOT intended as a substitute for standard medical care; intended to complement prescribed medication

  • DOSAGE & ADMINISTRATION

    Directions: Initially, depress pump until primed. Hold close to mouth and spray directly into mouth. Use 3 times daily. Use additionally as needed. Adults: 3 pumps sprays. Children 2-12:2 pump sprays

  • INACTIVE INGREDIENT

    Inactive Ingredients: Citric acid, potassium sorbate, pure water

  • INFORMATION FOR PATIENTS

    The letters HPUS indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States

    All Native Remedies health products are especially formulated by experts in the field of natural health and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness. For more information, visit us at www.nativeremedies.com

    Distributed by
    Native Remedies, LLC
    6531 Park of Commerce Blvd.
    Suite 160
    Boca Raton, FL 33487
    Phone: +1.877.289.1235
    International: 1.561.999.8857

    No gluten, artificial flavors, or colorants added

  • STORAGE AND HANDLING

    Tamper resistant for your protection. Use only if safety seal is intact

  • PRINCIPAL DISPLAY PANEL

    Bottle Label

  • INGREDIENTS AND APPEARANCE
    ALLERGYEASE SHELLFISH AND SEAFOOD 
    adrenalinum, belladona, bromium, carbo animalis, colchicum autumnale, colocynthis, histaminum hydrochloricum, hydrstis canadensis, kali carbonicum, lycopodium clavatum, mercuris solubilis, pulsatilla, urtica urens spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68703-124
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH) EPINEPHRINE12 [hp_X]  in 59 mL
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA12 [hp_X]  in 59 mL
    BROMINE (UNII: SBV4XY874G) (BROMINE - UNII:SBV4XY874G) BROMINE12 [hp_X]  in 59 mL
    Carbo Animalis (UNII: 279O8I0433) (Carbo Animalis - UNII:279O8I0433) Carbo Animalis12 [hp_X]  in 59 mL
    COLCHICUM AUTUMNALE BULB (UNII: 993QHL78E6) (COLCHICUM AUTUMNALE BULB - UNII:993QHL78E6) COLCHICUM AUTUMNALE BULB12 [hp_X]  in 59 mL
    CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT PULP12 [hp_X]  in 59 mL
    HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE12 [hp_X]  in 59 mL
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL12 [hp_X]  in 59 mL
    POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) POTASSIUM CARBONATE12 [hp_X]  in 59 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE12 [hp_X]  in 59 mL
    MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS12 [hp_X]  in 59 mL
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS12 [hp_X]  in 59 mL
    URTICA URENS (UNII: IHN2NQ5OF9) (URTICA URENS - UNII:IHN2NQ5OF9) URTICA URENS12 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68703-124-5959 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/13/2013
    Labeler - Native Remedies, LLC (192014186)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio617901350manufacture(68703-124) , api manufacture(68703-124)
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