Label: COLIC- beta vulgaris, carduus marianus, lappa major, aluminium metallicum, arsenicum album, chelidonium majus, hydrastis canadensis, lycopodium clavatum, natrum sulphuricum, nux vomica, phsophorus 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 21, 2015

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  • ACTIVE INGREDIENTS:

    Beta Vulgaris 3X, Carduus Marianus 3X, Lappa Major 3X, Aluminium Metallicum 12X, Arsenicum Album 12X, Chelidonium Majus 12X, Hydrastis Canadensis 12X, Lycopodium Clavatum 12X, Natrum Sulphuricum 12X, Nux Vomica 12X, Phsophorus 12X.

  • INDICATIONS:

    For temporary relief of bloating and fullness of the abdomen, flatulence, painful menses, abdominal cramping and colic.

  • WARNINGS:

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

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

    Do not use if tamper evident seal is broken or missing.

    Store in cool, dry place.

  • KEEP OUT OF REACH OF CHILDREN:

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS:

    10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

  • INDICATIONS:

    For temporary relief of bloating and fullness of the abdomen, flatulence, painful menses, abdominal cramping and colic.

  • INACTIVE INGREDIENTS:

    Demineralized Water, 25% Ethanol

  • QUESTIONS:

    Distributed by:

    BIOACTIVE NUTRITIONAL

    Melbourne, FL 32935

    For Nutritional Information write:

    BioActive Nutritional, Inc.

    1803 N. Wickham Rd.

    Melbourne, FL 32935

  • PACKAGE LABEL DISPLAY:

    BioActive Homeopathic

    COLIC

    1 FL OZ (30 ml)

    COLIC

  • INGREDIENTS AND APPEARANCE
    COLIC 
    beta vulgaris, carduus marianus, lappa major, aluminium metallicum, arsenicum album, chelidonium majus, hydrastis canadensis, lycopodium clavatum, natrum sulphuricum, nux vomica, phsophorus liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0369
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BETA VULGARIS (UNII: 4G174V5051) (BETA VULGARIS - UNII:4G174V5051) BETA VULGARIS3 [hp_X]  in 1 mL
    MILK THISTLE (UNII: U946SH95EE) (MILK THISTLE - UNII:U946SH95EE) MILK THISTLE3 [hp_X]  in 1 mL
    ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) (ARCTIUM LAPPA ROOT - UNII:597E9BI3Z3) ARCTIUM LAPPA ROOT3 [hp_X]  in 1 mL
    ALUMINUM (UNII: CPD4NFA903) (ALUMINUM - UNII:CPD4NFA903) ALUMINUM12 [hp_X]  in 1 mL
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE12 [hp_X]  in 1 mL
    CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS12 [hp_X]  in 1 mL
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL12 [hp_X]  in 1 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE12 [hp_X]  in 1 mL
    SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750) SODIUM SULFATE12 [hp_X]  in 1 mL
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED12 [hp_X]  in 1 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43857-0369-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/21/2015
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0369) , api manufacture(43857-0369) , label(43857-0369) , pack(43857-0369)
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