Label: DIARRHEA- cinchona officinalis, bryonia, chamomilla, colocynthis, ipecacuanha, belladonna tablet, chewable

  • 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 April 29, 2014

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  • Active ingredients HPUS:

    Cinchona officinalis (Calisaya bark) 8X

    Bryonia (White bryony) 8X

    Chamomilla (German chamomile) 8X

    Colocynthis (Bitter apple) 8X

    Ipecacuanha (Ipecac) 8X

    Belladonna (Deadly nightshade) 8X

  • Purpose

    diarrhea after eating fruit

    cramp-like pain, colic, diarrhea

    nausea after eating

    cramps, colic, diarrhea

    nausea, diarrhea

    diarrhea and nauseousness

  • REFERENCES

    The letters 'HPUS' indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

    *These statements have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice.

    Uses

    This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms of diarrhea:

    - diarrhea

    - painful cramps

    - nausea

  • Warnings

    Stop use and ask a doctor if symptoms worsen or persist for more than 3 days.

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

  • Directions

    • Chew tablets and let dissolve in mouth.

    • Do not use more than directed.

    • Do not take with food.

    • Repeat every 4 hours, and reduce intake with improvement or as directed by a health professional.

    AgeDose
    Adults and children 12 years of age and older2 tablets
    Children 2 to 11 years of age1 tablet

  • Other information

    Store at room temperature (68 - 77F).

    Do not use if the imprinted safety seal under cap is broken or missing.

  • Inactive ingredients

    Lactose, magnesium stearate.

  • CARTON

    image of carton label

  • INGREDIENTS AND APPEARANCE
    DIARRHEA 
    cinchona officinalis, bryonia, chamomilla, colocynthis, ipecacuanha, belladonna tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-846
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK8 [hp_X]
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT8 [hp_X]
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA8 [hp_X]
    CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT PULP8 [hp_X]
    IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC8 [hp_X]
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA8 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-846-061 in 1 CARTON
    160 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/29/2014
    Labeler - CVS PHARMACY (062312574)
    Registrant - HOMEOLAB USA INC (202032533)
    Establishment
    NameAddressID/FEIBusiness Operations
    HOMEOLAB USA INC202032533manufacture(59779-846)
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