Label: GABA (gaba- gamma-aminobutyric acid liquid

  • NDC Code(s): 43857-0123-1
  • Packager: BioActive Nutritional, Inc.
  • Category: HUMAN OTC DRUG LABEL

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

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  • ACTIVE INGREDIENT:

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

  • INDICATIONS:

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

  • 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.

  • 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 anxiety, irritability, anger and hostility.

  • INACTIVE INGREDIENTS:

    Demineralized Water, 25% Ethanol

  • QUESTIONS:

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

  • PACKAGE LABEL DISPLAY:

    BIOActive Nutritional

    GABA

    HOMEOPATHIC

    1 FL OZ (30 ml)

    GABA

  • INGREDIENTS AND APPEARANCE
    GABA 
    gaba (gamma-aminobutyric acid) liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0123
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    .GAMMA.-AMINOBUTYRIC ACID (UNII: 2ACZ6IPC6I) (.GAMMA.-AMINOBUTYRIC ACID - UNII:2ACZ6IPC6I) .GAMMA.-AMINOBUTYRIC ACID6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43857-0123-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product08/16/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/03/2014
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0123) , api manufacture(43857-0123) , label(43857-0123) , pack(43857-0123)
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