Label: FOOD INTOLERANCES- allium sativum, anacardium orientale, apis mellifica, gambogia, mercurius solubilis, natrum carbonicum, nitricum acidum, nux vomica, 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 February 21, 2018

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  • ACTIVE INGREDIENT

    Drug Facts​__________________________________________________________________________________________________________

    HPUS active ingredients: Allium sativum, Anacardium orientale, Apis Mellifica, Gambogia, Mercurius solubilis, Natrum carbonicum, Nitricum acidum, Nux vomica, Phosphorus, Pulsatilla, Sulphur

    Equal volumes of each ingredient in 10X, 30X, and 1LM potencies.

  • INDICATIONS & USAGE

    Uses ​for temporary relief of symptoms from food chemical intolerances and sensitivities: headache, irritability, stomach cramps, indigestion, nausea, constipation, diarrhea, gas, heartburn, bloating.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Bio-Energetically Enhanced™ pure water, Carya ovata bark extract (hickory), citrus extract, Lonicera japonica (honeysukle), polylysine (natural ferment), steviol glycosides (stevia).

  • WARNINGS

    Warnings

    • If symptoms persist or worsen, consult a physician.
    • 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 2-12: 2 sprays 3 times per day.
    • Use additionally as needed, up tp to 6 times per day.
  • OTHER SAFETY INFORMATION

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

  • PURPOSE

    Purpose:

    Allium sativum.....heavy head

    Anacardium orientale......nausea

    Apis Mellifica......nausea, headache, irritability

    Gambogia........gas, boating

    Mercurius solubilis.....sensitive stomach

    Natrum carbonicum.....headache

    Nitricum acidum....nausea after eating

    Nux vomica....constipation, diarrhea

    Phosphorus....heartburn

    Pulsatilla.....stomach cramps after eating

    Sulphur......headache, irritability, sensitive stomach

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    FOOD INTOLERANCES 
    allium sativum, anacardium orientale, apis mellifica, gambogia, mercurius solubilis, natrum carbonicum, nitricum acidum, nux vomica, phosphorus, pulsatilla, sulphur liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-0728
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GARLIC (UNII: V1V998DC17) (GARLIC - UNII:V1V998DC17) GARLIC10 [hp_X]  in 59 mL
    SEMECARPUS ANACARDIUM JUICE (UNII: Y0F0BU8RDU) (SEMECARPUS ANACARDIUM JUICE - UNII:Y0F0BU8RDU) SEMECARPUS ANACARDIUM JUICE10 [hp_X]  in 59 mL
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA10 [hp_X]  in 59 mL
    GAMBOGE (UNII: 7556HJ7587) (GAMBOGE - UNII:7556HJ7587) GAMBOGE10 [hp_X]  in 59 mL
    MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS10 [hp_X]  in 59 mL
    SODIUM CARBONATE (UNII: 45P3261C7T) (CARBONATE ION - UNII:7UJQ5OPE7D) SODIUM CARBONATE10 [hp_X]  in 59 mL
    NITRIC ACID (UNII: 411VRN1TV4) (NITRIC ACID - UNII:411VRN1TV4) NITRIC ACID10 [hp_X]  in 59 mL
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED10 [hp_X]  in 59 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS10 [hp_X]  in 59 mL
    ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA10 [hp_X]  in 59 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR10 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARYA OVATA BARK (UNII: X765CF609L)  
    CITRUS BIOFLAVONOIDS (UNII: BD70459I50)  
    LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
    POLYEPSILON-LYSINE (4000 MW) (UNII: WB0M8X4TWR)  
    REBAUDIOSIDE A (UNII: B3FUD0528F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57955-0728-21 in 1 CARTON02/21/2018
    159 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/21/2018
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350manufacture(57955-0728)
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