Label: ADRENAL AND DHEA- american ginseng, arnica montana, avena sativa flowering top, silybum marianum seed, prasterone, sus scrofa adrenal gland, arginine, sodium chloride, phosphoric acid, thuja occidentalis leaf and .alpha.-tocopherol liquid 

  • NDC Code(s): 43853-0008-1, 43853-0008-2, 43853-0008-3
  • Packager: ProBLEN
  • 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 04/13

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENTS

    Aralia Quinquefolia 3X, Arnica Montana 3X, Avena Sativa 3X, Carduus Marianus 3X, DHEA 6X, Glandula Suprarenalis Suis 12X, L-Arginine 6X, Natrum Muriaticum 30C, Phosphoricum Acidum 200C, Thuja Occidentalis 200C, Vitamin E 10X

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  • INDICATIONS

    Temporarily supports the body to rebalance Adrenal and DHEA output.  Symptoms of imbalanced Adrenal and DHEA may include: low energy, depression, anxiety, dry eyes, skin, and hair, loss of head hair. 

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  • WARNINGS

    Not for use on children.  If symptoms continue to recur, or if sleeplessness persists continuously for more than two weeks, consult a physician.  Insomnia may be a symptom of a serious underlying medical illness.  As with all medicines, if you are pregnant or breast feeding, consult a health professional before using this product.  Keep out of the reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.

    There is a seal around the neck of the bottle.  Do not use if this seal is broken or missing.

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  • DIRECTIONS

    Adults: Hold the spray-top close to your open mouth and spray twice directly under your tongue, three times a day.  Some people notice improvement within two or three weeks, others take longer. 

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  • INACTIVE INGREDIENTS

    Purified Water, Organic Ethanol 20%

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  • KEEP OUT OF REACH OF CHILDREN

    In case of overdose, get medical help or contact a Poison Control Center right away.

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  • INDICATIONS AND USAGE

    Temporarily supports the body to rebalance Adrenal and DHEA output. Symptoms of imbalanced Adrenal and DHEA may include: low energy, depression, anxiety, dry eyes, skin, and hair, loss of head hair.

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  • QUESTIONS

    Distributed By ProBLEN

    2850 Shoreline Trail

    Rockwall, TX 75032

    www.problen.com

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  • PRINCIPAL DISPLAY PANEL

    HOMEOPATHIC

    ORGANOTHERAPY

    Adrenal and

    DHEA

    1.0 FL OZ. (30 ML)

    proBLEN

    Adrenal and DHEA

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  • INGREDIENTS AND APPEARANCE
    ADRENAL AND DHEA 
    aralia quinquefolia, arnica montana, avena sativa, carduus marianus, dhea, glandula suprarenalis suis, l-arginine liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:43853-0008
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AMERICAN GINSENG (AMERICAN GINSENG) AMERICAN GINSENG 3 [hp_X]  in 1 mL
    ARNICA MONTANA (ARNICA MONTANA) ARNICA MONTANA 3 [hp_X]  in 1 mL
    AVENA SATIVA FLOWERING TOP (AVENA SATIVA FLOWERING TOP) AVENA SATIVA FLOWERING TOP 3 [hp_X]  in 1 mL
    SILYBUM MARIANUM SEED (SILYBUM MARIANUM SEED) SILYBUM MARIANUM SEED 3 [hp_X]  in 1 mL
    PRASTERONE (PRASTERONE) PRASTERONE 6 [hp_X]  in 1 mL
    SUS SCROFA ADRENAL GLAND (SUS SCROFA ADRENAL GLAND) SUS SCROFA ADRENAL GLAND 12 [hp_X]  in 1 mL
    ARGININE (ARGININE) ARGININE 6 [hp_X]  in 1 mL
    SODIUM CHLORIDE (CHLORIDE ION) SODIUM CHLORIDE 30 [hp_X]  in 1 mL
    PHOSPHORIC ACID (PHOSPHORIC ACID) PHOSPHORIC ACID 200 [hp_C]  in 1 mL
    THUJA OCCIDENTALIS LEAF (THUJA OCCIDENTALIS LEAF) THUJA OCCIDENTALIS LEAF 200 [hp_C]  in 1 mL
    .ALPHA.-TOCOPHEROL (.ALPHA.-TOCOPHEROL) .ALPHA.-TOCOPHEROL 10 [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:43853-0008-3 1 in 1 CARTON
    1 NDC:43853-0008-2 1 in 1 CARTON
    1 NDC:43853-0008-1 30 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 04/23/2013
    Labeler - ProBLEN (838787161)
    Registrant - Apotheca Company (844330915)
    Establishment
    Name Address ID/FEI Business Operations
    Apotheca Company 844330915 manufacture(43853-0008)
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