Label: INDIGESTION- lycopodium clavatum, carduus marianus, chelidonium majus, boldo, nux vomica 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 May 22, 2014

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  • Active ingredients HPUS:

    Lycopodium clavatum (Clubmoss) 8X

    Carduus marianus (Milk thistle) 8X

    Chelidonium majus (Calandine) 8X

    Boldo (Chilean sassafras) 8X

    Nux vomica (Poison nut) 8X

  • Purpose

    heartburn, nausea

    burping acidity, nausea

    upset stomach, bilious vomiting

    slow digestion, digestion discomfort

    indigestion from overeating

  • 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 associated with indigestion*:

    - heartburn

    - upset stomach

    - digestive discomfort

  • Warnings

    Stop use and ask a doctor if symptoms worsen or persist for more than 7 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 3 times daily and reduce 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
    INDIGESTION 
    lycopodium clavatum, carduus marianus, chelidonium majus, boldo, nux vomica tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-847
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE8 [hp_X]
    SILYBUM MARIANUM SEED (UNII: U946SH95EE) (MILK THISTLE - UNII:U946SH95EE) SILYBUM MARIANUM SEED8 [hp_X]
    CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS8 [hp_X]
    PEUMUS BOLDUS LEAF (UNII: Q4EWM09M3O) (PEUMUS BOLDUS LEAF - UNII:Q4EWM09M3O) PEUMUS BOLDUS LEAF8 [hp_X]
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED8 [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:59779-847-061 in 1 CARTON
    160 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/22/2014
    Labeler - CVS PHARMACY (062312574)
    Registrant - HOMEOLAB USA INC (202032533)
    Establishment
    NameAddressID/FEIBusiness Operations
    HOMEOLAB USA INC202032533manufacture(59779-847)
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