Label: CYCLEASE PMS- estrone, sodium chloride, sepia officinalis juice tablet

  • 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 May 30, 2023

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  • ACTIVE INGREDIENT

    Folliculinum 15C HPUS (0.8mg), Natrum muriaticum 12C HPUS (0.8mg), Sepia 12C HPUS (0.8mg)

  • INDICATIONS & USAGE

    Temporary relieves premenstrual symptoms such as: bloating, water retention, minor aches, lower back pain, discomfort, emotional changes, irritability

  • DO NOT USE

    Do not use if glued carton end flaps are open or if the blister seal is broken

  • DOSAGE & ADMINISTRATION

    Adults and children 12 years of age and older: Dissolve 2 tablets in the mouth morning and evening until symptoms are relieved.
    Children under 12 years of age: Not recommended

  • INACTIVE INGREDIENT

    Croscarmellose sodium, lactose, magnesium stearate

  • HOW SUPPLIED

    60 meltaway tablets

  • PURPOSE

    Folliculinum 15C ...Relieves discomfort and aches associated with PMS
    Natrum muriaticum 12C ...Relieves water retention and irritability
    Sepia 12C...Relieves bloating and lower back pain.

  • STORAGE AND HANDLING

    Store at 68-77 o F (30 oC)

  • QUESTIONS

    Questions, Comments

    Boironusa.com

    info@boironusa.com

    1-800-BOIRON-1

    (1-800-264-7661)

    Distributed by Boiron, Inc.

    Newtown Square, PA 19073

  • ASK DOCTOR


  • STOP USE

    Stop use and ask a doctor if symptoms persist for more than 7 days or worsen.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children
    In case of accidental overdose, get medical help or contact a Poison Control Center right away.

  • PREGNANCY OR BREAST FEEDING

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

  • WHEN USING


  • DRUG INTERACTIONS

    Safe - no side effects - no drug interactions - works naturally with your body

  • WARNINGS

    Enter section text here

  • SPL UNCLASSIFIED SECTION

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

    *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.

  • PRINCIPAL DISPLAY PANEL

    labelbox

  • INGREDIENTS AND APPEARANCE
    CYCLEASE PMS 
    estrone, sodium chloride, sepia officinalis juice tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-9081
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ESTRONE (UNII: 2DI9HA706A) (ESTRONE - UNII:2DI9HA706A) ESTRONE15 [hp_C]
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE12 [hp_C]
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE12 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUND (BOIRON) Size9mm
    FlavorImprint Code ;
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0220-9081-0460 in 1 BLISTER PACK; Type 0: Not a Combination Product08/12/2002
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/12/2002
    Labeler - Laboratoires Boiron (282560473)
    Registrant - Boiron Inc. (014892269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boiron282560473manufacture(0220-9081)
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