Label: STRENGTH M- aralia quinquefolia, avena sativa, damiana, epimedium grandiflorum, glutathione, l-arginine, l-leucine, l-ornithine, l-valine, testosterone, sabal serrulata, sepia 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 January 19, 2017

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  • ACTIVE INGREDIENTS:

    Aralia Quinquefolia 3X, Avena Sativa 3X, Damiana 3X, Epimedium Grandiflorum 6X, Glutathione 6X, L-Arginine 6X, L-Leucine 6X, L-Ornithine 6X, L-Valine 6X, Testosterone 12X, Sabal Serrulata 24X, Sepia 30X.

  • INDICATIONS:

    For temporary relief of muscular exhaustion, debility after exercise and lowered vitality in the male after exercise.

  • 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.

  • 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.

  • DIRECTIONS:

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

  • INDICAITONS:

    For temporary relief of muscular exhaustion, debility after exercise and lowered vitality in the male after exercise.

  • INACTIVE INGREDIENTS:

    Demineralized Water, 25% Ethanol

  • QUESTIONS:

    Distributed by:
    BioActive Nutritional, Inc.
    1803 N. Wickham Rd.
    Melbourne, FL 32935
    bioactivenutritional.com

  • PACKAGE LABEL DISPLAY:

    BIOActive Nutritional

    STRENGTH M

    HOMEOPATHIC

    1 FL OZ (30 ml)

    Strenght M

  • INGREDIENTS AND APPEARANCE
    STRENGTH M 
    aralia quinquefolia, avena sativa, damiana, epimedium grandiflorum, glutathione, l-arginine, l-leucine, l-ornithine, l-valine, testosterone, sabal serrulata, sepia liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0428
    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
    AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP3 [hp_X]  in 1 mL
    TURNERA DIFFUSA LEAFY TWIG (UNII: RQ2CFA7WWJ) (TURNERA DIFFUSA LEAFY TWIG - UNII:RQ2CFA7WWJ) TURNERA DIFFUSA LEAFY TWIG3 [hp_X]  in 1 mL
    EPIMEDIUM GRANDIFLORUM TOP (UNII: 137PC46F89) (EPIMEDIUM GRANDIFLORUM TOP - UNII:137PC46F89) EPIMEDIUM GRANDIFLORUM TOP6 [hp_X]  in 1 mL
    GLUTATHIONE (UNII: GAN16C9B8O) (GLUTATHIONE - UNII:GAN16C9B8O) GLUTATHIONE6 [hp_X]  in 1 mL
    ARGININE (UNII: 94ZLA3W45F) (ARGININE - UNII:94ZLA3W45F) ARGININE6 [hp_X]  in 1 mL
    LEUCINE (UNII: GMW67QNF9C) (LEUCINE - UNII:GMW67QNF9C) LEUCINE6 [hp_X]  in 1 mL
    ORNITHINE (UNII: E524N2IXA3) (ORNITHINE - UNII:E524N2IXA3) ORNITHINE6 [hp_X]  in 1 mL
    VALINE (UNII: HG18B9YRS7) (VALINE - UNII:HG18B9YRS7) VALINE6 [hp_X]  in 1 mL
    TESTOSTERONE (UNII: 3XMK78S47O) (TESTOSTERONE - UNII:3XMK78S47O) TESTOSTERONE12 [hp_X]  in 1 mL
    SAW PALMETTO (UNII: J7WWH9M8QS) (SAW PALMETTO - UNII:J7WWH9M8QS) SAW PALMETTO24 [hp_X]  in 1 mL
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE30 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43857-0428-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product01/19/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/19/2017
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0428) , api manufacture(43857-0428) , label(43857-0428) , pack(43857-0428)
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