Label: LOWER GI RELIEF- natural medicine 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 17, 2011

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  • Active Ingredients

    HPUS active ingredients

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

    Aethusa cynapium

    Althaea officinalis

    Alumina

    Antimonium crudum

    Arsenicum album

    Baptisia tinctoria

    Bismuthum subnitricum

    Carbo vegetabilis

    Chamomilla

    Cinchona officinalis

    Collinsonia canadensis

    Colocynthis

    Condurango

    Gambogia

    Graphites

    Gratiola officinalis

    Juglans cinerea

    Lac defloratum

    Lac vaccinum

    Natrum carbonicum

    Nux vomica

    Podophyllum peltatum

    sepia

    Silicea

    Reference image lower gi.jpg

  • Inactive Ingredient

    Bio-Energetically Enhanced, taste-free pure water base.

    Reference image lower gi.jpg

  • Purpose

    HPUS active ingredients                                    Purpose

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

    Aethusa cynapium.........................................nausea, vomiting

    Althaea officinalis...........................................gastrointestinal inflammation

    Alumina.........................................................constipation, heavy sensation

    Antimonium crudum.......................................bloating, gas

    Arsenicum album...........................................distended abdomen

    Baptisia tinctoria............................................abdominal soreness

    Bismuthum subnitricum..................................diarrhea

    Carbo vegetabilis...........................................gas

    Chamomilla...................................................flatulence

    Cinchona officinalis........................................slow digestion

    Collinsonia canadensis...................................hemorrhoids, constipation

    Colocynthis...................................................sore abdomen, pain

    Condurango..................................................burning pain, vomiting

    Gambogia.....................................................irritable stomach

    Graphites.....................................................gas, diarrhea

    Gratiola officinalis.........................................cramping, intestinal mucus

    Juglans cinerea............................................abdominal soreness

    Lac defloratum.............................................nausea, constipation

    Lac vaccinum..............................................bloating, pain

    Natrum carbonicum......................................weak digestion

    Nux vomica.................................................flatulence, sore abdomen

    Podophyllum peltatum..................................diarrhea, hemorrhoids

    Sepia...........................................................burning pain, constipation

    Silicea..........................................................rumbling in bowels

    Reference image lower gi.jpg
  • Warnings


    If symptoms persist or worsen, seek advice of physician. If pregnant or nursing, take only on advice of a healthcare professional. Keep out of reach of children.

    Other information

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

    Reference image lower gi.jpg

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    Reference image lower gi.jpg

  • Dosage

    Directions Initially, depress pump until primed. Hold close to mouth and spray one dose directly into mouth.

    Adult Dose- 3 pump sprays 3 times per day. Use additionally as needed.

    Children 2-12 years- 2 pump sprays 3 times per day. Use additionally as needed.

    Reference image lower gi.jpg

  • Indications and Usage

    Uses temporarily relieves symptoms of lower gastrointestinal distress:

    • constipation
    • gas
    • bloating
    • diarrhea
    • abdominal cramping
    • gastrointestinal inflammation
    • hemorrhoids
    • flatulence
    as per various homeopathic Materia Medicas.

    Reference image lower gi.jpg
  • PRINCIPAL DISPLAY PANEL

    image of carton label



    King Bio Inc.

    3 Westside Drive

    Asheville, NC 28806

    www.kingbio.com


    Reference image lower gi.jpg

  • INGREDIENTS AND APPEARANCE
    LOWER GI RELIEF 
    natural medicine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-6321
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AETHUSA CYNAPIUM (UNII: M6936L953C) (AETHUSA CYNAPIUM - UNII:M6936L953C) AETHUSA CYNAPIUM10 [hp_X]  in 59 mL
    ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H) (ALTHAEA OFFICINALIS ROOT - UNII:TRW2FUF47H) ALTHAEA OFFICINALIS ROOT10 [hp_X]  in 59 mL
    ALUMINUM OXIDE (UNII: LMI26O6933) (ALUMINUM OXIDE - UNII:LMI26O6933) ALUMINUM OXIDE10 [hp_X]  in 59 mL
    ANTIMONY TRISULFIDE (UNII: F79059A38U) (SULFATE ION - UNII:7IS9N8KPMG) ANTIMONY TRISULFIDE10 [hp_X]  in 59 mL
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC TRIOXIDE - UNII:S7V92P67HO) ARSENIC TRIOXIDE10 [hp_X]  in 59 mL
    BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU) BAPTISIA TINCTORIA ROOT10 [hp_X]  in 59 mL
    BISMUTH SUBNITRATE (UNII: H19J064BA5) (BISMUTH SUBNITRATE - UNII:H19J064BA5) BISMUTH SUBNITRATE10 [hp_X]  in 59 mL
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL10 [hp_X]  in 59 mL
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA10 [hp_X]  in 59 mL
    CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK10 [hp_X]  in 59 mL
    COLLINSONIA CANADENSIS ROOT (UNII: O2630F3XDR) (COLLINSONIA CANADENSIS ROOT - UNII:O2630F3XDR) COLLINSONIA CANADENSIS ROOT10 [hp_X]  in 59 mL
    CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT PULP10 mL  in 59 mL
    GAMBOGE (UNII: 7556HJ7587) (GAMBOGE - UNII:7556HJ7587) GAMBOGE10 [hp_X]  in 59 mL
    GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE10 [hp_X]  in 59 mL
    GRATIOLA OFFICINALIS (UNII: BDD9991A36) (GRATIOLA OFFICINALIS - UNII:BDD9991A36) GRATIOLA OFFICINALIS10 [hp_X]  in 59 mL
    JUGLANS CINEREA BRANCH BARK/ROOT BARK (UNII: 48FZ1BHO18) (JUGLANS CINEREA BRANCH BARK/ROOT BARK - UNII:48FZ1BHO18) JUGLANS CINEREA BRANCH BARK/ROOT BARK10 [hp_X]  in 59 mL
    SKIM MILK (UNII: 6A001Y4M5A) (SKIM MILK - UNII:6A001Y4M5A) SKIM MILK10 [hp_X]  in 59 mL
    COW MILK (UNII: 917J3173FT) (COW MILK - UNII:917J3173FT) COW MILK10 [hp_X]  in 59 mL
    SODIUM CARBONATE (UNII: 45P3261C7T) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CARBONATE10 [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
    PODOPHYLLUM (UNII: 2S713A4VP3) (PODOPHYLLUM - UNII:2S713A4VP3) PODOPHYLLUM10 [hp_X]  in 59 mL
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE10 [hp_X]  in 59 mL
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE10 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57955-6321-21 in 1 CARTON
    159 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/01/2011
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350manufacture
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