Label: NAJA FORTE X- naja tripudians liquid

  • NDC Code(s): 43857-0151-1
  • 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 May 16, 2016

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  • ACTIVE INGREDIENTS:

    Naja Tripudians 9X, 12X, 30X.

  • INDICATIONS:

    For temporary relief of pain in left temple and in left orbital region, extending to occiput with nausea and vomiting, brooding over imaginary troubles, melancholy, aversion to talking and dreads to be left alone.

  • 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 cool, dry place.

  • DIRECTIONS:

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

  • INACTIVE INGREDIENTS:

    Demineralized Water, 25% Ethanol.

  • 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.

  • INDICATIONS:

    For temporary relief of pain in left temple and in left orbital region, extending to occiput with nausea and vomiting, brooding over imaginary troubles, melancholy, aversion to talking and dreads to be left alone.

  • QUESTIONS:

    Distributed by:

    BioActive Nutritional, Inc.

    1803 N. Wickham Rd

    Melbourne, FL 32935

    bioactivenutritional.com

  • PACKAGE LABEL DISPLAY:

    BIOActive Nutritional

    NAJA FORTE X

    HOMEOPATHIC

    1 FL OZ (30 ml)

    Naja Forte

  • INGREDIENTS AND APPEARANCE
    NAJA FORTE X 
    naja tripudians liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0151
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAJA NAJA VENOM (UNII: ZZ4AG7L7VM) (NAJA NAJA VENOM - UNII:ZZ4AG7L7VM) NAJA NAJA VENOM9 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43857-0151-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product04/03/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/03/2013
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0151) , api manufacture(43857-0151) , label(43857-0151) , pack(43857-0151)
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