Label: ALLERGIES DAIRY- aethusa cynapium, anacardium orientale apium graveolens, calcarea carbonicum, gambogia, histaminum hydrochloricum, hydrastis canadensis, lac defloratum, lac vaccinum, pulsatilla, sepia, 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 December 19, 2016

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  • ACTIVE INGREDIENT

    Drug Facts​__________________________________________________________________________________________________________

    HPUS active ingredients: Aethusa cynapium, Anacardium orientale, Apium graveolens, Calcarea carbonica, Gambogia, Histaminum hydrochloricum, Hydrastis canadensis, Lac defloratum, Lac vaccinum, Pulsatilla, Sepia, Sulphur​. Equal volumes of each ingredient in 12X, 24X, 30C, 1LM, 2LM, 3LM, 5LM potencies.

  • INDICATIONS & USAGE

    Uses ​for fast relief of symptoms from dairy allergies (cow & goat) or lactose intolerance: mucous congestion, sinusitis, runny nose, heartburn, skin irritations, earaches, constipation or diarrhea, fatigue, mood swings.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Bio-Energetically Enhanced™ pure water, citric acid and potassium sorbate.

  • WARNINGS

    Warnings

    • Stop use and ask your doctor if symptoms persist or worsen.
    • If pregnant or breast-feeding, take only on advice of a healthcare professional.
  • 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 12 and up: 3 sprays 3 times per day.
    • Children 2-12: 2 sprays 3 times per day.
    • ​Children 2 mo-2yr: 1 spray 3 times per day.
  • OTHER SAFETY INFORMATION

    Tamper resistant for your protection. Use only if seal is intact. This product has not been clinically tested.

  • PURPOSE

    Uses for fast relief of symptoms from dairy allergies (cow & goat) or lactose intolerance:

    • mucous congestion
    • sinusitis
    • runny nose
    • heartburn
    • skin irritations
    • earaches
    • constipation or diarrhea
    • fatigue
    • mood swings
  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ALLERGIES DAIRY 
    aethusa cynapium, anacardium orientale apium graveolens, calcarea carbonicum, gambogia, histaminum hydrochloricum, hydrastis canadensis, lac defloratum, lac vaccinum, pulsatilla, sepia, sulphur liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-2198
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SEMECARPUS ANACARDIUM JUICE (UNII: Y0F0BU8RDU) (SEMECARPUS ANACARDIUM JUICE - UNII:Y0F0BU8RDU) SEMECARPUS ANACARDIUM JUICE12 [hp_X]  in 59 mL
    AETHUSA CYNAPIUM (UNII: M6936L953C) (AETHUSA CYNAPIUM - UNII:M6936L953C) AETHUSA CYNAPIUM12 [hp_X]  in 59 mL
    CELERY SEED (UNII: 1G1EAA320L) (CELERY SEED - UNII:1G1EAA320L) CELERY SEED12 [hp_X]  in 59 mL
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE12 [hp_X]  in 59 mL
    GAMBOGE (UNII: 7556HJ7587) (GAMBOGE - UNII:7556HJ7587) GAMBOGE12 [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
    SKIM MILK (UNII: 6A001Y4M5A) (SKIM MILK - UNII:6A001Y4M5A) SKIM MILK12 [hp_X]  in 59 mL
    COW MILK (UNII: 917J3173FT) (COW MILK - UNII:917J3173FT) COW MILK12 [hp_X]  in 59 mL
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS12 [hp_X]  in 59 mL
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE12 [hp_X]  in 59 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57955-2198-259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/13/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/13/2015
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350manufacture(57955-2198)
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