Label: GALLIC ACID- gallicum acidum liquid

  • 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 September 25, 2013

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  • ACTIVE INGREDIENTS:

    Gallicum Acidum 6X, 12X, 30X, 12C, 30C

  • INDICATIONS:

    For temporary relief of allergic rhinitis, general fatigue, nasal congestion, joint pain, lower back pain, headaches, dyspepsia, and itching.

  • WARNINGS:

    ​If pregnant or breast-feeding,​ ask a health care professional before use.

    ​Keep out of reach of children.​ In case of overdose, get medial 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 medial help or contact a Poison Control Center right away.

  • DIRECTTIONS:

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

  • INDICATIONS:

    For temporary relief of allergic rhinitis, general fatigue, nasal congestion, joint pain, lower back pain, headaches, dyspepsia, and itching.

  • INACTIVE INGREDIENTS:

    Demineralized Water, 25% Ethanol

  • QUESTIONS:

    Distributed by:

    BIOACTIVE NUTRITIONAL

    Melbourne, FL 32935

    For Nutritional Information write:

    BioActive Nutritional, Inc.

    1803 N. Wickham Rd.

    Melbourne, FL 32935

  • PACKAGE DISPLAY LABEL:

    ​BioActive Homeopathic

    GALLIC ACID

    1 FL OZ (30 ml)

    image description

  • INGREDIENTS AND APPEARANCE
    GALLIC ACID 
    gallicum acidum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0234
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GALLIC ACID MONOHYDRATE (UNII: 48339473OT) (GALLIC ACID - UNII:632XD903SP) GALLIC ACID MONOHYDRATE6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43857-0234-130 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/23/2013
    Labeler - BioActive Nutritional (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0234) , api manufacture(43857-0234) , label(43857-0234) , pack(43857-0234)
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