Label: ADRENAL TONIC- aralia quinquefolia, glycyrrhiza glabra, sarsaparilla, avena sativa, glandula suprarenalis bovine, adrenalinum, arsenicum album, kali phosphoricum, natrum muriaticum, nux vomica, phosphoricum acidum, veratrum album 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 May 23, 2016

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

  • ACTIVE INGREDIENTS:

    Aralia Quinquefolia 1X, Glycyrrhiza Glabra 1X, Sarsaparilla 1X, 12X, Avena Sativa 3X, Glandula Suprarenalis Bovine 8X, Adrenalinum 12X, 30X, Arsenicum Album 12X, Kali Phosphoricum 12X, Natrum Muriaticum 12X, Nux Vomica 12X, Phosphoricum Acidum 12X, Veratrum Album 12X.

  • INDICATIONS:

    For temporary relief of marked debility producing nervous exhaustion, weakness and exhaustion following acute illness; and rheumatic pains in the sacrum and joints with muscular weakness.

  • 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 cool, dry place.

  • DIRECTIONS:

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

  • INACTIVE INGREDIENTS:

    Demineralized Water, 25% Ethanol.

  • 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:

    For temporary relief of marked debility producing nervous exhaustion, weakness and exhaustion following acute illness; and rheumatic pains in the sacrum and joints with muscular weakness.

  • QUESTIONS:

    Distributed by:

    BioActive Nutritional, Inc.

    1803 N. Wickham Rd.

    Melbourne, FL 32935

    bioactivenutritional.com

  • PACKAGE LABEL DISPLAY:

    BIOActive Nutritional

    ADRENAL TONIC

    HOMEOPATHIC

    1 FL OZ (30 ml)

    Adrenal Tonic

  • INGREDIENTS AND APPEARANCE
    ADRENAL TONIC 
    aralia quinquefolia, glycyrrhiza glabra, sarsaparilla, avena sativa, glandula suprarenalis bovine, adrenalinum, arsenicum album, kali phosphoricum, natrum muriaticum, nux vomica, phosphoricum acidum, veratrum album liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0057
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMERICAN GINSENG (UNII: 8W75VCV53Q) (AMERICAN GINSENG - UNII:8W75VCV53Q) AMERICAN GINSENG1 [hp_X]  in 1 mL
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) (GLYCYRRHIZA GLABRA - UNII:2788Z9758H) GLYCYRRHIZA GLABRA1 [hp_X]  in 1 mL
    SMILAX REGELII ROOT (UNII: 2H1576D5WG) (SARSAPARILLA - UNII:2H1576D5WG) SMILAX REGELII ROOT1 [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
    BOS TAURUS ADRENAL GLAND (UNII: M2776SWB29) (BOS TAURUS ADRENAL GLAND - UNII:M2776SWB29) BOS TAURUS ADRENAL GLAND8 [hp_X]  in 1 mL
    EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH) EPINEPHRINE12 [hp_X]  in 1 mL
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE12 [hp_X]  in 1 mL
    POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) POTASSIUM PHOSPHATE, DIBASIC12 [hp_X]  in 1 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE12 [hp_X]  in 1 mL
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED12 [hp_X]  in 1 mL
    PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID12 [hp_X]  in 1 mL
    VERATRUM ALBUM ROOT (UNII: QNS6W5US1Z) (VERATRUM ALBUM ROOT - UNII:QNS6W5US1Z) VERATRUM ALBUM ROOT12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43857-0057-160 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product05/23/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/23/2016
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0057) , api manufacture(43857-0057) , label(43857-0057) , pack(43857-0057)