Label: GABA- gaba (gamma-aminobutyric acid) liquid

  • NDC Code(s): 43857-0123-1
  • Packager: BioActive Nutritional, Inc.
  • 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 August 17, 2016

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

  • ACTIVE INGREDIENT:

    GABA (Gamma-Aminobutyric Acid) 6X, 12X, 30X, 12C, 30C.

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  • INDICATIONS:

    For temporary relief of anxiety, irritability, anger and hostility.

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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 anxiety, irritability, anger and hostility.

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  • INACTIVE INGREDIENTS:

    Demineralized Water, 25% Ethanol

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  • QUESTIONS:

    Distributed by:
    BioActive Nutritional, Inc.
    1803 N. Wickham Rd.
    Melbourne, FL 32935
    bioactivenutritional.com

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  • PACKAGE LABEL DISPLAY:

    BIOActive Nutritional

    GABA

    HOMEOPATHIC

    1 FL OZ (30 ml)

    GABA

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  • INGREDIENTS AND APPEARANCE
    GABA 
    gaba (gamma-aminobutyric acid) liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:43857-0123
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    .GAMMA.-AMINOBUTYRIC ACID (UNII: 2ACZ6IPC6I) (.GAMMA.-AMINOBUTYRIC ACID - UNII:2ACZ6IPC6I) .GAMMA.-AMINOBUTYRIC ACID 6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:43857-0123-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 08/16/2016
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 10/03/2014
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    Name Address ID/FEI Business Operations
    Apotheca Company 844330915 manufacture(43857-0123) , api manufacture(43857-0123) , label(43857-0123) , pack(43857-0123)
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