Label: CAUSTICUM 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 20, 2023

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

  • ACTIVE INGREDIENT

    Active ingredient** (in each pellet)

    Causticum 30C HPUS (0.44 mg)

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

  • PURPOSE

    Purpose*

    Relieves symptoms of stress incontinence

  • INDICATIONS & USAGE

    Uses*

    • temporarily relieves occasional stress incontinence associated with
    • coughing
    • laughing
    • sneezing
    • exercise
    • lifting objects
    • helps with urine retention issues due to
    • aging
    • menopause
    • childbirth

    Tube- Bed wetting and bladder incontinence*

  • WARNINGS

  • DO NOT USE

    Do not use if you have any of these symptoms:

    • pain or burning when urinating
    • fever or chills
    • blood in your urine
    • unexplained back or side pain
    • urine that is cloudy or foul smelling.
  • ASK DOCTOR

    Ask a doctor before use if you have any of these conditions:

    • urinary tract infection
    • fever or chills
    • blood in your urine
    • unexplained back or side pain
    • urinary or gastric retention.
  • STOP USE

    Box - Stop use and ask a doctor if symptoms persist for more than 2 weeks or worsen.

    Tube- 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. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Box

    • Adults 18 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.
    • Adults under 18 years of age: Not recommended.

    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.

  • SPL UNCLASSIFIED SECTION

    • do not use if glued carton end flaps are open or if pellet dispenser seal is broken
    • contains 0.25 g of sugar per dose

    Incontinence Relief*

    Reduces Bladder Leaks*

    For Occasional Stress Incontinence*

    No Know Drug Interactions

    3 TUBES

    APPROX. 80 PELLETS EACH

    TOTAL 240 PELLETS

    16 DOSES PER TUBE

    Turn tube upside down Twist until 5 pellets are dispensed Remove cap and pour pellets under the tongue

    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.

  • INACTIVE INGREDIENT

    lactose, sucrose

  • 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

    labellabel

  • INGREDIENTS AND APPEARANCE
    CAUSTICUM 
    causticum pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-1233
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM30 [hp_C]  in 30 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorwhiteScore    
    ShapeROUNDSize4mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0220-1233-4130 [hp_C] in 1 TUBE; Type 0: Not a Combination Product03/03/1983
    2NDC:0220-1233-433 in 1 BOX05/11/2022
    230 [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(0220-1233)