Label: RUTA GRAVEOLENS- ruta graveolens flowering top 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 June 11, 2024

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

  • ACTIVE INGREDIENT

    Active ingredient** (in each pellet)

    Ruta graveolens 6C HPUS
    (** contains 0.44 mg of the active ingredient per pellet)

    The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

  • PURPOSE

    Relieves eye strain, fatigue, and burning due to computer use, artificial light, or visually demanding tasks

  • INDICATIONS & USAGE

    Eye Strain Relief Uses*

    temporarily relieves symptoms of minor eye strain associated with use of digital devices, artificial or poor light, and visually demanding tasks such as:

    • fatigue
    • burning
    • tired eyes

    Tube Uses*

    Relieves eye strain due to computer use or artificial lights *

  • WARNINGS

  • STOP USE

    Eye Strain Relief Carton

    Stop use and ask a doctor if you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours.

    Tube

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

  • PREGNANCY OR BREAST FEEDING

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

  • 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.

  • DOSAGE & ADMINISTRATION

    Eye Strain Relief Carton

    • Adults and children 6 years and older: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.
    • Children under 6 years of age: Ask a doctor.

    Tube

    Adults and children: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.

  • INACTIVE INGREDIENT

    lactose, sucrose

  • SPL UNCLASSIFIED SECTION

    Eye Strain Relief Carton

    Eye Strain Relief*

    Fatique, Burning, Tired Eyes*

    3 Tubes

    16 Doses

    Total 240 Pellets

    do not use if glued carton end flaps are open or if pellet dispenser seal is broken

    contains 0.25g of sugar per dose

    retain carton for full drug facts

    Turn tube upside down. Twist until 5 pellets are dispensed into cap. Carefully remove the cap and use it to pour pellets under the tongue.

    Tube

    Do not use if pellet dispenser seal is broken.
    Contains approx 80 pellets.
    How to dispense pellets? Turn tube upside down. Twist until 5 pellets are dispensed into cap. Carefully remove the cap and use it to pour pellets under the tongue.
    *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
    *C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.

  • QUESTIONS

    BoironUSA.com Info@boiron.com
    1-800-BOIRON-1
    (1-800-264-7661)
    Distributed by Boiron, Inc.
    Newtown Square, PA 19073

  • PRINCIPAL DISPLAY PANEL

    labellabellabel

  • INGREDIENTS AND APPEARANCE
    RUTA GRAVEOLENS 
    ruta graveolens flowering top pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-4463
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP6 [hp_C]  in 6 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    Product Characteristics
    ColorwhiteScore    
    ShapeROUNDSize4mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0220-4463-416 [hp_C] in 1 TUBE; Type 0: Not a Combination Product03/03/1983
    2NDC:0220-4463-433 in 1 BOX06/11/2024
    2NDC:0220-4463-416 [hp_C] in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/03/1983
    Labeler - Boiron (282560473)
    Registrant - Boiron, Inc. (014892269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boiron282560473manufacture(0220-4463)