Label: ALLERGYEASE GRAIN AND GLUTEN- arsenicum album, bryonia alba, histamimum hydrochloricum, hydrastis canadensis, lycopodium clavatum, natrum muriaticum, pulsatilla, sabadilla, secale cornutum, sulphur 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 5, 2013

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

  • PURPOSE

    Relieves symptoms of grain and gluten sensitivity

  • ACTIVE INGREDIENT

    Drug Facts
    Active Ingredients:
    Equal volumes of each ingredient in 12X, 24X, LM1 potencies: Arsenicum album, Bryonia alba, Histaminum hydrochloricum, Hydrastis canadensis, Lycopodium clavatum, Natrum muriaticum, Pulsatilla, Sabadilla, Secale cornutum, Sulphur

  • INDICATIONS & USAGE

    Uses:Temporarily relieves symptoms from grains and gluten: cramps, diarrhea, nausea, constipation, skin irritations, indigestions, congestions, headaches, and sinusitis

  • 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

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all medication out of reach of children

  • OVERDOSAGE

    In case of overdose, get medical help or contact a Poison Control Center right away

  • 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 pumps sprays

  • INACTIVE INGREDIENT

    Inactive Ingredients: Citric acid, potassium sorbate, pure water

  • INFORMATION FOR PATIENTS

    The letter 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 Suite 160
    Boca Raton, FL 33487
    Phone:+1.877.289.1235
    International:1.561.999.8857

    No gluten, artificial flavors, animal products, 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 GRAIN AND GLUTEN  
    arsenicum album, bryonia alba, histamimum hydrochloricum, hydrastis canadensis, lycopodium clavatum, natrum muriaticum, pulsatilla, sabadilla, secale cornutum, sulphur spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68703-102
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE12 [hp_X]  in 59 mL
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT12 [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
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE12 [hp_X]  in 59 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE12 [hp_X]  in 59 mL
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS12 [hp_X]  in 59 mL
    SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO) SCHOENOCAULON OFFICINALE SEED12 [hp_X]  in 59 mL
    CLAVICEPS PURPUREA SCLEROTIUM (UNII: 01G9XEA93N) (CLAVICEPS PURPUREA SCLEROTIUM - UNII:01G9XEA93N) CLAVICEPS PURPUREA SCLEROTIUM12 [hp_X]  in 59 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [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:68703-102-5959 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/05/2013
    Labeler - Native Remedies, LLC (192014186)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio617901350manufacture(68703-102) , api manufacture(68703-102)