Label: UPPER GI RESTORATION- aceticum acidum, agaricus muscarius, aloe socotrina, antimonium crudum, argentum nitricum, carbo vegetabilis, carduus marianus, chelidonium majus, chenopodium anthelminticum, cinchona officinalis, graphites, ipecacuanha, lac defloratum, mentha piperita, nux vomica, secale cornutum, tanacetum vulgare, teucrium marum, zingiber officinale 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 October 22, 2013

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

  • ACTIVE INGREDIENT

    Drug Facts

    ___________________________________________________________________________________________________________________

    HPUS active ingredients: Aceticum acidum, Agaricus muscarius, Aloe socotrina, Antimonium crudum, Argentum nitricum, Carbo vegetabilis, Carduus marianus, Chelidonium majus, Chenopodium anthelminticum, Cinchona officinalis, Graphites, Ipecacuanha, Lac defloratum, Mentha piperita, Nux vomica, Secale cornutum, Tanacetum vulgare, Teucrium marum, Zingiber officinale. Equal volumes of each ingredient in 10X, 30X, 100X, 1M, LM1, LM2, LM3 potencies.

  • INDICATIONS & USAGE

    Uses temporarily relieves symptoms of upper gastrointestinal distress: heartburn, gas, nausea, bloating, slow digestion, flatulence, vomiting, sensitive stomach.

  • INACTIVE INGREDIENT

    Inactive ingredients: Bio-Energetically Enhanced™ pure water base, citric acid, 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: 3 sprays 3 times per day.
    • Children 2-12 years: 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.

  • PURPOSE

    Uses temporarily relieves symptoms of upper gastrointestinal distress:

    • heartburn
    • gas
    • nausea
    • bloating
    • slow digestion
    • flatulence
    • vomiting
    • sensitive stomach
  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    UPPER GI RESTORATION 
    aceticum acidum, agaricus muscarius, aloe socotrina, antimonium crudum, argentum nitricum, carbo vegetabilis, carduus marianus, chelidonium majus, chenopodium anthelminticum, cinchona officinalis, graphites, ipecacuanha, lac defloratum, mentha piperita, nux vomica, secale cornutum, tanacetum vulgare, teucrium marum, zingiber officinale liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-0321
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETIC ACID (UNII: Q40Q9N063P) (ACETIC ACID - UNII:Q40Q9N063P) ACETIC ACID10 [hp_X]  in 59 mL
    AMANITA MUSCARIA FRUITING BODY (UNII: DIF093I037) (AMANITA MUSCARIA FRUITING BODY - UNII:DIF093I037) AMANITA MUSCARIA FRUITING BODY10 [hp_X]  in 59 mL
    ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9) ALOE10 [hp_X]  in 59 mL
    ANTIMONY TRISULFIDE (UNII: F79059A38U) (ANTIMONY TRISULFIDE - UNII:F79059A38U) ANTIMONY TRISULFIDE10 [hp_X]  in 59 mL
    SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE10 [hp_X]  in 59 mL
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL10 [hp_X]  in 59 mL
    SILYBUM MARIANUM SEED (UNII: U946SH95EE) (SILYBUM MARIANUM SEED - UNII:U946SH95EE) SILYBUM MARIANUM SEED10 [hp_X]  in 59 mL
    CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS10 [hp_X]  in 59 mL
    DYSPHANIA AMBROSIOIDES (UNII: 4H5RSU087I) (CHENOPODIUM AMBROSIOIDES - UNII:4H5RSU087I) DYSPHANIA AMBROSIOIDES10 [hp_X]  in 59 mL
    CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK10 [hp_X]  in 59 mL
    GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE10 [hp_X]  in 59 mL
    IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC10 [hp_X]  in 59 mL
    SKIM MILK (UNII: 6A001Y4M5A) (SKIM MILK - UNII:6A001Y4M5A) SKIM MILK10 [hp_X]  in 59 mL
    MENTHA PIPERITA (UNII: 79M2M2UDA9) (MENTHA PIPERITA - UNII:79M2M2UDA9) MENTHA PIPERITA10 [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
    CLAVICEPS PURPUREA SCLEROTIUM (UNII: 01G9XEA93N) (CLAVICEPS PURPUREA SCLEROTIUM - UNII:01G9XEA93N) CLAVICEPS PURPUREA SCLEROTIUM10 [hp_X]  in 59 mL
    TANACETUM VULGARE TOP (UNII: D52957JQ8M) (TANACETUM VULGARE TOP - UNII:D52957JQ8M) TANACETUM VULGARE TOP10 [hp_X]  in 59 mL
    TEUCRIUM MARUM (UNII: 10464S0TAA) (TEUCRIUM MARUM - UNII:10464S0TAA) TEUCRIUM MARUM10 [hp_X]  in 59 mL
    GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ) GINGER10 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57955-0321-259 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/22/2013
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350api manufacture(57955-0321)