Label: RUTA GRAVEOLENS- ruta graveolens flowering top pellet 

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 10/13

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

  • ACTIVE INGREDIENT HPUS

    RUTA GRAVEOLENS 3X & HIGHER

    (Rue)

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  • PURPOSE

    STRAINS AND PAIN

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  • USE

    For self-limiting condition listed above or as directed by a health professional.

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  • WARNINGS

    Do not use if pellet-dispenser seal is broken.

    Stop use and ask a doctor if symptoms persist more than 3 days or worsen.

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

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  • DIRECTIONS

    Adults: Allow 3 or 4 pellets to dissolve in the mouth 3 times a day until symptoms are relieved or as directed by a health professional.

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  • OTHER INFORMATION

    Store at room temperature.

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  • INACTIVE INGREDIENTS

    Lactose, sucrose.

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  • QUESTIONS?

    1-800-404-4666

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  • REFERENCES

    The letters 'HPUS' indicate that the component in this product is officially monographed in the Homeopathic Pharmacopoeia of the United States.


    These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice.

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  • DESCRIPTION

    80 Pellets

    Pellet dispenser

    Mfd for: HOMEOLAB USA INC., 3025 De L`Assomption, Montreal, QC, H1N 2H2, CANADA

    Product of Canada

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  • LABEL
  • INGREDIENTS AND APPEARANCE
    RUTA GRAVEOLENS 
    ruta graveolens pellet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:60512-1041
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    RUTA GRAVEOLENS FLOWERING TOP (RUTA GRAVEOLENS FLOWERING TOP) RUTA GRAVEOLENS FLOWERING TOP 3 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    LACTOSE  
    SUCROSE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:60512-1041-1 80 in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 10/11/1995
    Labeler - HOMEOLAB USA INC. (202032533)
    Registrant - HOMEOLAB USA INC. (202032533)
    Establishment
    Name Address ID/FEI Business Operations
    HOMEOLAB USA INC. 202032533 manufacture(60512-1041)
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