Label: TUBERCULINUM RESIDUUM 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 January 18, 2023

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  • ACTIVE INGREDIENT

    TUBERCULINUM RESIDUUM 30C

    (**contains 0.443 mg of the active ingredient per pellet)

  • PURPOSE

  • INDICATIONS & USAGE

    Relieves stiffness and pain associated with minor arthritis*

  • WARNINGS

  • STOP USE

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

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • SPL UNCLASSIFIED SECTION

    Do not use if pellet dispenser seal is broken.
    Contains approx 80 quick dissolving pellets per tube.
    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.

  • INACTIVE INGREDIENT

    lactose, sucrose

  • DOSAGE & ADMINISTRATION

    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.

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    TUBERCULINUM RESIDUUM 
    tuberculinum residuum pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-5066
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TUBERCULINUM RESIDUUM (UNII: X4R8E2P3V3) (TUBERCULINUM RESIDUUM - UNII:X4R8E2P3V3) TUBERCULINUM RESIDUUM30 [hp_C]  in 30 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Colorwhite, whiteScore    
    ShapeSize4mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0220-5066-4130 [hp_C] in 1 TUBE; Type 0: Not a Combination Product10/14/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/14/2022
    Labeler - Boiron (282560473)
    Registrant - Boiron, Inc. (014892269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boiron282560473manufacture(0220-5066)
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