Label: BIO OLIVE- olea europaea flower liquid

  • NDC Code(s): 43857-0236-1
  • Packager: BioActive Nutritional, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 10/13

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENTS:

    Olea Europaea, Flos 6X, 30C, 200C.

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  • INDICATIONS:

    For temporary relief of exhaustion, drained energy.

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  • 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 a cool, dry place.

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  • 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.

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  • DIRECTIONS:

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

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  • INDICATIONS:

    For temporary relief of exhaustion, drained energy.

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  • INACTIVE INGREDIENTS:

    Demineralized Water, 25% Ethanol

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  • QUESTIONS:

    Distributed by:

    BIOACTIVE NUTRITIONAL

    Melbourne, FL 32935

    For Nutritional Information write:

    BioActive Nutritional, Inc.

    1803 N. Wickham Rd.

    Melbourne, FL 32935

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  • PACKAGE DISPLAY LABEL:

    ​BioActive Homeopathic

    BIO OLIVE 6X, 30C, 200C

    1 FL OZ (30 ml)

    Bio Olive

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  • INGREDIENTS AND APPEARANCE
    BIO OLIVE 
    olea europaea liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:43857-0236
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OLEA EUROPAEA FLOWER (OLEA EUROPAEA FLOWER) OLEA EUROPAEA FLOWER 6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    ALCOHOL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:43857-0236-1 30 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 10/02/2013
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    Name Address ID/FEI Business Operations
    Apotheca Company 844330915 manufacture(43857-0236), api manufacture(43857-0236), label(43857-0236), pack(43857-0236)
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