Label: FOOD INTOLERANCES- aethusa cynapium, calcarea carbonica, cucurbita pepo, semen, gambogia, histaminum hydrochloricum, hydrastis canadensis, lycopodium clavatum, natrum carbonicum, nitricum acidum, nux vomica, ovi gallinae pellicula, phosphorus, pulsatilla, sulphur 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 November 4, 2013

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

  • ACTIVE INGREDIENT

    Drug Facts

    ____________________________________________________________________________________________________________

    Equal volumes of each ingredient in 10X, 30X, and LM1 potencies.

    HPUS active ingredients: Aethusa cynapium, Calcarea carbonica, Cucurbita pepo, semen, Gambogia, Histaminum hydrochloricum, Hydrastis canadensis, Lycopodium clavatum, Natrum carbonicum, Nitricum acidum, Nux vomica, Ovi gallinae pellicula, Phosphorus, Pulsatilla, Sulphur.

  • INDICATIONS & USAGE

    Uses for temporary relief of symptoms associated with food intolerances and sensitivities:

    • headache
    • irritability
    • stomach cramps and indigestion
    • nausea
    • gas, heartburn and bloating
    • constipation
    • diarrhea
    • sensitivities to meat, fat, salt, dairy, starches and vegetables.
  • WARNINGS

    Warnings

    • Stop use and ask a doctor if symptoms persist or worsen.
    • If pregnant or breast-feeding, ask a healthcare professional before use.
  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children.
  • DOSAGE & ADMINISTRATION

    Directions:

    • Initially, depress pump until primed.
    • Spray one dose directly into mouth.
    • Adults: 3 sprays 3 times per day.
    • Children ages 6-12: 2 sprays 3 times per day.
    • Use additionally as needed, up to 6 times per day.
  • OTHER SAFETY INFORMATION

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

    • This product is intended to complement, not replace, standard medical care.
  • INACTIVE INGREDIENT

    Inactive Ingredients: Citric acid, potassium sorbate, purified water.

  • PURPOSE

    Drug Facts

    __________________________________________________________________________________________________________________

    HPUS active ingredients                                                                    Purpose

    Equal volumes of each ingredient in 10X, 30X, and LM1 potencies.

    Aethusa cynapium..........................................................................headache, irritability

    Calcarea carbonica.........................................................................aversion to meat, fat and milk

    Cucurbita pepo, semen...................................................................nausea after eating

    Gambogia.....................................................................................sneezing, diarrhea

    Histaminum hydrochloricum............................................................stomach cramps

    Hydrastis canadensis......................................................................sensitivities to bread or vegetables

    Lycopodium clavatum.....................................................................indigestion

    Natrum carbonicum........................................................................sensitivities to milk, diarrhea

    Nitricum acidum.............................................................................constipation

    Nux vomica...................................................................................nausea after eating, stomach cramps

    Ovi gallinae pellicula.......................................................................sensitivities to eggs

    Phosphorus....................................................................................sensitivities to salt, nausea

    Pulsatilla........................................................................................gas, heartburn, bloating

    Sulphur..........................................................................................loss of appetite, sensitivities to dairy

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    FOOD INTOLERANCES 
    aethusa cynapium, calcarea carbonica, cucurbita pepo, semen, gambogia, histaminum hydrochloricum, hydrastis canadensis, lycopodium clavatum, natrum carbonicum, nitricum acidum, nux vomica, ovi gallinae pellicula, phosphorus, pulsatilla, sulphur liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-8300
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AETHUSA CYNAPIUM (UNII: M6936L953C) (AETHUSA CYNAPIUM - UNII:M6936L953C) AETHUSA CYNAPIUM10 [hp_X]  in 29.6 mL
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE10 [hp_X]  in 29.6 mL
    PUMPKIN SEED (UNII: GH30P1VXK2) (PUMPKIN SEED - UNII:GH30P1VXK2) PUMPKIN SEED10 [hp_X]  in 29.6 mL
    GAMBOGE (UNII: 7556HJ7587) (GAMBOGE - UNII:7556HJ7587) GAMBOGE10 [hp_X]  in 29.6 mL
    HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE10 [hp_X]  in 29.6 mL
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL10 [hp_X]  in 29.6 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE10 [hp_X]  in 29.6 mL
    SODIUM CARBONATE (UNII: 45P3261C7T) (CARBONATE ION - UNII:7UJQ5OPE7D) SODIUM CARBONATE10 [hp_X]  in 29.6 mL
    NITRIC ACID (UNII: 411VRN1TV4) (NITRIC ACID - UNII:411VRN1TV4) NITRIC ACID10 [hp_X]  in 29.6 mL
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED10 [hp_X]  in 29.6 mL
    EGG SHELL MEMBRANE (UNII: N7QBR4212V) (EGG SHELL MEMBRANE - UNII:N7QBR4212V) EGG SHELL MEMBRANE10 [hp_X]  in 29.6 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS10 [hp_X]  in 29.6 mL
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS10 [hp_X]  in 29.6 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR10 [hp_X]  in 29.6 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:57955-8300-11 in 1 CARTON
    129.6 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/04/2013
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350api manufacture(57955-8300)