Label: ADRENAL AND DHEA- aralia quinquefolia, arnica montana, avena sativa, carduus marianus, dhea, glandula suprarenalis suis, l-arginine, natrum muriaticum, phosphoricum acidum, thuja occidentalis, vitamin e, spray

  • 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 December 20, 2010

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  • ACTIVE INGREDIENT

    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.


  • PURPOSE

    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.

  • WARNINGS

    WARNINGS:  Nor 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 reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.

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


  • DOSAGE & ADMINISTRATION

    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.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:  Organic alcohol 20% v/v, Purified water.


  • 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 & USAGE

    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.

  • QUESTIONS

    Distributed By  ProBLEN

    2850 Shoreline Trail

    Rockwall, TX 75032

    www.problen.com


  • PRINCIPAL DISPLAY PANEL

    HOMEOPATHIC

    ORGANOTHERAPY

    Adrenal and DHEA

    proBLEN

    1 FL OZ (30 ML)

    Adrenal and DHEA

  • INGREDIENTS AND APPEARANCE
    ADRENAL AND DHEA 
    aralia quinquefolia, arnica montana, avena sativa, carduus marianus, dhea, glandula suprarenalis suis, l-arginine, natrum muriaticum, phosphoricum acidum, thuja occidentalis, vitamin e, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50845-0086
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMERICAN GINSENG (UNII: 8W75VCV53Q) (AMERICAN GINSENG - UNII:8W75VCV53Q) AMERICAN GINSENG3 [hp_X]  in 1 mL
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA3 [hp_X]  in 1 mL
    AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP3 [hp_X]  in 1 mL
    SILYBUM MARIANUM SEED (UNII: U946SH95EE) (SILYBUM MARIANUM SEED - UNII:U946SH95EE) SILYBUM MARIANUM SEED3 [hp_X]  in 1 mL
    PRASTERONE (UNII: 459AG36T1B) (PRASTERONE - UNII:459AG36T1B) PRASTERONE6 [hp_X]  in 1 mL
    SUS SCROFA ADRENAL GLAND (UNII: 398IYQ16YV) (SUS SCROFA ADRENAL GLAND - UNII:398IYQ16YV) SUS SCROFA ADRENAL GLAND12 [hp_X]  in 1 mL
    ARGININE (UNII: 94ZLA3W45F) (ARGININE - UNII:94ZLA3W45F) ARGININE6 [hp_X]  in 1 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE30 [hp_C]  in 1 mL
    PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID200 [hp_C]  in 1 mL
    THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG200 [hp_C]  in 1 mL
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) (ALPHA-TOCOPHEROL - UNII:H4N855PNZ1) ALPHA-TOCOPHEROL10 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50845-0086-31 in 1 CARTON
    1NDC:50845-0086-21 in 1 CARTON
    1NDC:50845-0086-130 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/20/2010
    Labeler - Liddell Laboratories, Inc. (832264241)
    Establishment
    NameAddressID/FEIBusiness Operations
    Liddell Laboratories, Inc.832264241manufacture
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