Label: FATIGUE RELIEF- alfalfa, phosphorus, avena sativa, selenium metallicum, agnus castus, phosphoricum acidum pellet

  • 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 November 6, 2013

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  • ACTIVE INGREDIENTS HPUS

    Alfalfa 2X

    Phosphorus 6X

    Avena sativa 2X

    Selenium metallicum 9X

    Agnus castus 2X

    Phosphoricum acidum 9X

  • REFERENCES

    Manufactured according to the Homeopathic Pharmacopoeia of the United States (HPUS)

  • PURPOSE

    Support for Occurrences of Mental or Physical Fatigue

  • USES

    This is a natural Homeopathic support for occurrences of mental and physical fatigue.

  • WARNINGS

  • ASK DOCTOR

    If symptoms persist or worsen, discontinue use and contact a health professional.

  • PREGNANCY OR BREAST FEEDING

    As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all medications out of reach of children.

  • DIRECTIONS

    Adults: Allow 3 to 4 pellets to dissolve in mouth three times a day.

    Children under 12: Take 1/2 the adult dose.

  • OTHER INFORMATION

    Do not use if cap seal is broken.

    Homeolab USA Inc., 3025 De L'Assomption Blvd., Montreal, QC H1N 2H2  Canada

    PRODUCT OF CANADA

  • CARTON

    IMAGE OF CARTONIMAGE OF LABEL

  • INGREDIENTS AND APPEARANCE
    FATIGUE RELIEF 
    alfalfa, phosphorus, avena sativa, selenium metallicum, agnus castus, phosphoricum acidum pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60512-0010
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALFALFA WHOLE (UNII: DJO934BRBD) (ALFALFA - UNII:DJO934BRBD) ALFALFA WHOLE2 [hp_X]
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS6 [hp_X]
    AVENA SATIVA LEAF (UNII: 206PI19V7R) (AVENA SATIVA LEAF - UNII:206PI19V7R) AVENA SATIVA LEAF2 [hp_X]
    SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM9 [hp_X]
    CHASTE TREE (UNII: 433OSF3U8A) (CHASTE TREE - UNII:433OSF3U8A) CHASTE TREE2 [hp_X]
    PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID9 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    LACTOSE (UNII: J2B2A4N98G)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize4mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60512-0010-180 in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/18/2013
    Labeler - HOMEOLAB USA INC. (202032533)
    Establishment
    NameAddressID/FEIBusiness Operations
    HOMEOLAB USA INC.202032533manufacture(60512-0010)
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