GABA LIQUID [BIOACTIVE NUTRITIONAL, INC.]

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GABA LIQUID [BIOACTIVE NUTRITIONAL, INC.]
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NDC 43857-0149-1
Set ID 1240ee3c-b036-4b6b-a61a-b616e850ad40
Category HUMAN OTC DRUG LABEL
Packager BioActive Nutritional, Inc.
Generic Name
Product Class
Product Number
Application Number
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  • ACTIVE INGREDIENTS:

    Gaba 6X.

  • 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 6X

    HOMEOPATHIC

    1 FL OZ (30 ml)

    GABA 6X

  • INGREDIENTS AND APPEARANCE
    GABA 
    gaba liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0149
    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:43857-0149-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product06/15/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/10/2013
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0149) , api manufacture(43857-0149) , label(43857-0149) , pack(43857-0149)
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