Label: ADRENOPLEX - chelidonium majus, echinacea angustifolia, sus scrofa spleen, silybum marianum seed, lycopodium clavatum spore, sodium chloride, phosphoric acid and bos taurus adrenal gland liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 01/10

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  • ACTIVE INGREDIENT

    Active Ingredients:  Chelidonium Majus 3X, Echinacea Angustifolia 3X, Glandula Suprarenalis Bovinum 8X, Spleen 8X, Cardus Marianus 12X, Lycopodium Clavatum 12X, Natrum Muriaticum 12X, Phosphoricum Acidum 12X.

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  • PURPOSE

    Indications:  For temporary relief of nervous exhaustion, fatigue and forgetfulness.

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  • WARNINGS

    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.

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  • DOSAGE & ADMINISTRATION

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

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  • INACTIVE INGREDIENT

    Inactive Ingredients:  Demineralized Water, 25% Ethanol

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  • QUESTIONS

    Distributed By:      BioActive Nutritional

                                   Melbourne, FL 32935

    For Nutritional Information Write To:      BioActive Nutritional, Inc,

                                                                       1803 N Wickham Rd.

                                                                       Melbourne, FL 32935

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  • PRINCIPAL DISPLAY PANEL

    BioActive Homeopathic

    ADRENOPLEX

    1 FL OZ (30 ML)

    Adrenalplex

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  • INGREDIENTS AND APPEARANCE
    ADRENOPLEX 
    chelidonium majus, echinacea angustifolia liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:57520-0018
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CHELIDONIUM MAJUS (CHELIDONIUM MAJUS) CHELIDONIUM MAJUS 3 [hp_X]  in 1 mL
    ECHINACEA ANGUSTIFOLIA (ECHINACEA ANGUSTIFOLIA) ECHINACEA ANGUSTIFOLIA 3 [hp_X]  in 1 mL
    SUS SCROFA SPLEEN (SUS SCROFA SPLEEN) SUS SCROFA SPLEEN 8 [hp_X]  in 1 mL
    SILYBUM MARIANUM SEED (SILYBUM MARIANUM SEED) SILYBUM MARIANUM SEED 12 [hp_X]  in 1 mL
    LYCOPODIUM CLAVATUM SPORE (LYCOPODIUM CLAVATUM SPORE) LYCOPODIUM CLAVATUM SPORE 12 [hp_X]  in 1 mL
    SODIUM CHLORIDE (SODIUM CATION) SODIUM CHLORIDE 12 [hp_X]  in 1 mL
    PHOSPHORIC ACID (PHOSPHORIC ACID) PHOSPHORIC ACID 12 [hp_X]  in 1 mL
    BOS TAURUS ADRENAL GLAND (BOS TAURUS ADRENAL GLAND) BOS TAURUS ADRENAL GLAND 8 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    ALCOHOL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57520-0018-1 30 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 01/28/2010
    Labeler - Apotheca Company (844330915)
    Establishment
    Name Address ID/FEI Business Operations
    Apotheca Company 844330915 manufacture
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