Label: DIARRHEA RELIEF- aloe socotrina, chamomilla, cinchona officinalis, colocynthis, croton tigium, cuprum arsenicosum, gelsemium sempervirens, ipecacuanha, nux vomica, phosphoricum acidum, podophyllum peltatum, veratrum album 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 May 8, 2014

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  • ACTIVE INGREDIENT

    Drug Facts​__________________________________________________________________________________________________________

    HPUS activeingredients:  Aloe socotrina, Chamomilla, Cinchona officinalis, Colocynthis, Croton tiglium, Cuprum arsenicosum, Gelsemium sempervirens, Ipecacuanha, Nux vomica, Phosphoricum acidum, Podophyllum peltatum, Veratrum album. Equal volumes of each ingredient in 10X, 30X, 100X, 1M, LM1, LM2, LM3 potencies.

  • INDICATIONS & USAGE

    Uses for temporary relief of symptoms of diarrhea: loose and watery stools, cramps, gas and bloating, mucus in stools, jelly-like stool, sudden evacuation, intestinal gurgling, involuntary stools, diarrhea caused by certain foods or emotional excitement.

  • 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-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 temporary relief of symptoms of diarrhea:

    • loose and watery stools
    • cramps, gas and bloating
    • mucus in stools
    • jelly-like stool
    • sudden evacuation
    • intestinal gurgling
    • involuntary stools
    • diarrhea caused by certain foods or emotional excitement
  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    DIARRHEA RELIEF 
    aloe socotrina, chamomilla, cinchona officinalis, colocynthis, croton tigium, cuprum arsenicosum, gelsemium sempervirens, ipecacuanha, nux vomica, phosphoricum acidum, podophyllum peltatum, veratrum album liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-0020
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9) ALOE10 [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
    CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT PULP10 [hp_X]  in 59 mL
    CROTON TIGLIUM SEED (UNII: 0HK2GZK66E) (CROTON TIGLIUM SEED - UNII:0HK2GZK66E) CROTON TIGLIUM SEED10 [hp_X]  in 59 mL
    CUPRIC ARSENITE (UNII: SK8L60BCSQ) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC ARSENITE10 [hp_X]  in 59 mL
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT10 [hp_X]  in 59 mL
    IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC10 [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
    PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID10 [hp_X]  in 59 mL
    PODOPHYLLUM (UNII: 2S713A4VP3) (PODOPHYLLUM - UNII:2S713A4VP3) PODOPHYLLUM10 [hp_X]  in 59 mL
    VERATRUM ALBUM ROOT (UNII: QNS6W5US1Z) (VERATRUM ALBUM ROOT - UNII:QNS6W5US1Z) VERATRUM ALBUM ROOT10 [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:57955-0020-259 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/08/2014
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350manufacture(57955-0020)
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