Label: ADRENAL AND DHEA- aralia quinquefolia, ashwagandha, avena sativa, carduus marianus, dhea, glandula suprarenalis suis, l-arginine, natrum muriaticum, phosphoricum acidum, rhodiola. 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 9, 2019

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

  • ACTIVE INGREDIENT

    Active Ingredients Equal Parts Of: Aralia Quinquefolia 3X, Ashwagandha 3X, Avena Sativa 3X, Carduus Marianus 3X, DHEA 6X, Glandula Suprarenalis Suis 12X, L-Arginine 6X, Natrum Muriaticum 30C, Phosphoricum Acidum 200C, Rhadiola 3X.

  • 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: 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 orbreast feeding, consult a health professional before using this product. 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.

    Keep out of reach of children

  • 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.

  • 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:

    (888) 326-2121

    www.problen.com

    3021 Ridge Rd. Rockwall, TX 75032

  • PRINCIPAL DISPLAY PANEL

    NDC: 43853-0020-1

    Adrenal & DHEA

    HOMEOPATHIC

    ORGANOTHERAPY

    1.0 FL OZ. (30 ML) 20% ALCOHOL

    proBLEN

    image description

  • INGREDIENTS AND APPEARANCE
    ADRENAL AND DHEA 
    aralia quinquefolia, ashwagandha, avena sativa, carduus marianus, dhea, glandula suprarenalis suis, l-arginine, natrum muriaticum, phosphoricum acidum, rhodiola. liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43853-0020
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMERICAN GINSENG (UNII: 8W75VCV53Q) (AMERICAN GINSENG - UNII:8W75VCV53Q) AMERICAN GINSENG3 [hp_X]  in 30 mL
    WITHANIA SOMNIFERA ROOT (UNII: V038D626IF) (WITHANIA SOMNIFERA ROOT - UNII:V038D626IF) WITHANIA SOMNIFERA ROOT3 [hp_X]  in 30 mL
    AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP3 [hp_X]  in 30 mL
    MILK THISTLE (UNII: U946SH95EE) (MILK THISTLE - UNII:U946SH95EE) MILK THISTLE3 [hp_X]  in 30 mL
    PRASTERONE (UNII: 459AG36T1B) (PRASTERONE - UNII:459AG36T1B) PRASTERONE6 [hp_X]  in 30 mL
    SUS SCROFA ADRENAL GLAND (UNII: 398IYQ16YV) (SUS SCROFA ADRENAL GLAND - UNII:398IYQ16YV) SUS SCROFA ADRENAL GLAND12 [hp_X]  in 30 mL
    ARGININE (UNII: 94ZLA3W45F) (ARGININE - UNII:94ZLA3W45F) ARGININE6 [hp_X]  in 30 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE30 [hp_C]  in 30 mL
    PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID200 [hp_C]  in 30 mL
    RHODIOLA KIRILOWII ROOT (UNII: Y5M0NZV54F) (RHODIOLA KIRILOWII ROOT - UNII:Y5M0NZV54F) RHODIOLA KIRILOWII ROOT3 [hp_X]  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43853-0020-130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/09/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/09/2017
    Labeler - ProBLEN (838787161)
    Registrant - OHM PHARMA INC. (030572478)
    Establishment
    NameAddressID/FEIBusiness Operations
    OHM PHARMA INC.030572478manufacture(43853-0020)