Label: HEARTBURN RELIEF- abies nigra, arsenicum album, condurango, conium maculatum, iris versicolor, magnesia carbonica, robinia pseudoacacia, sulphuricum acidum 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 23, 2015

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  • ACTIVE INGREDIENT

    Drug Facts​__________________________________________________________________________________________________________

    HPUS active ingredients: ​Abies nigra, Arsenicum album, Condurango, Conium maculatum, Iris versicolor, Magnesia carbonica, Robinia pseudoacacia, Sulphuricum acidum. Equal volumes of each ingredient in 10X, 30X, 100X, 1M, LM1, LM2, LM3 potencies.

  • INDICATIONS & USAGE

    Uses for symptomatic relief of: acid reflux, burning pain, sour stomach, belching, indigestion, nausea, stomach spasms, stomach distention.

  • 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 years: 2 sprays 3 times per day
    • Children 2 mo-2 yr: 1 spray 3 times per day
  • OTHER SAFETY INFORMATION

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

  • PURPOSE

    Uses for symptomatic relief of:

    • acid reflux
    • burning pain
    • sour stomach
    • belching
    • indigestion
    • nausea
    • stomach spasms
    • stomach distention
  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    HEARTBURN RELIEF 
    abies nigra, arsenicum album, condurango, conium maculatum, iris versicolor, magnesia carbonica, robinia pseudoacacia, sulphuricum acidum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-0022
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PICEA MARIANA RESIN (UNII: 71AOV0W131) (PICEA MARIANA RESIN - UNII:71AOV0W131) PICEA MARIANA RESIN10 [hp_X]  in 59 mL
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE10 [hp_X]  in 59 mL
    MARSDENIA CONDURANGO BARK (UNII: R23QIR6YBA) (MARSDENIA CONDURANGO BARK - UNII:R23QIR6YBA) MARSDENIA CONDURANGO BARK10 [hp_X]  in 59 mL
    CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371) CONIUM MACULATUM FLOWERING TOP10 [hp_X]  in 59 mL
    IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC) IRIS VERSICOLOR ROOT10 [hp_X]  in 59 mL
    MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D) MAGNESIUM CARBONATE10 [hp_X]  in 59 mL
    ROBINIA PSEUDOACACIA BARK (UNII: 7TPC058OWY) (ROBINIA PSEUDOACACIA BARK - UNII:7TPC058OWY) ROBINIA PSEUDOACACIA BARK10 [hp_X]  in 59 mL
    SULFURIC ACID (UNII: O40UQP6WCF) (SULFURIC ACID - UNII:O40UQP6WCF) SULFURIC ACID10 [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:57955-0022-259 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/06/2012
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350manufacture(57955-0022)
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