GABA (GABA (GAMMA-AMINOBUTYRIC ACID)) LIQUID [BIOACTIVE NUTRITIONAL, INC.]

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GABA (GABA (GAMMA-AMINOBUTYRIC ACID)) LIQUID [BIOACTIVE NUTRITIONAL, INC.]
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NDC 43857-0123-1
Set ID 4fe29a89-c4d6-446c-b5f7-692762c58614
Category HUMAN OTC DRUG LABEL
Packager BioActive Nutritional, Inc.
Generic Name
Product Class
Product Number
Application Number
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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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