Label: CYCLEASE MENOPAUSE- arnica montana whole, black cohosh, nitroglycerin, lachesis muta venom, sanguinaria canadensis root 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 April 1, 2021

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

  • ACTIVE INGREDIENT

    Active ingredients** (in each tablet)

    Arnica montana 4C HPUS (0.5mg)

    Cimicifuga racemosa 4C HPUS (0.5mg)

    Glonoinum 4C HPUS (0.5mg)

    Lachesis mutus 5C HPUS (0.5mg)

    Sanguinaria canadensis 4C HPUS (0.5mg) (contains less than 10 -9 mg chelidonine alkaloids)

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

  • PURPOSE

    Purpose*

    Arnica montana 4C HPUS (0.5mg) ... Relieves red, blotchy face associated with hot flashes

    Cimicifuga racemosa 4C HPUS (0.5mg) ... Relieves mood changes, irritability, and occasional sleeplessness associated with menopause

    Glonoinum 4C HPUS (0.5mg) ... Relieves sudden hot flashes with profuse sweating and throbbing headache associated with menopause

    Lachesis mutus 5C HPUS (0.5mg) ... Relieves hot flashes, night sweats, irritability, and mood changes associated with menopause

    Sanguinaria canadensis 4C HPUS (0.5mg) ... Relieves flushing of the face associated with menopause

  • INDICATIONS & USAGE

    Uses*

    temporarily relieves symptoms associated with perimenopause and menopause such as:

    • hot flashes
    • red, blotchy or flushed face
    • night sweats
    • mood changes
    • irritability
    • occasional sleeplessness

    temporarily reduces the intensity and frequency of hot flashes associated with perimenopause and menopause

  • WARNINGS

    Warnings

  • STOP USE

    Stop use and ask a doctor if symptoms persist 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 accidental overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    Adults: At the onset of symptoms, day or night, allow 1 tablet to slowly dissolve in the mouth up to 4 times in 24 hours. Daily use for 3 months is recommended.

    Children: Not recommended.

  • SPL UNCLASSIFIED SECTION

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

    Store below 86° F (30° C)

    60 meltaway tablets unflavored

    Hormone & Soy Relief

    Menopause relief*

    Hot Flashes Night Sweats Mood Changes*

    No Known Drug Interactions

    Day & Night Relief

    *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, magnesium stearate, sucrose

  • QUESTIONS

    Questions or comments?

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

    Made in France

  • PRINCIPAL DISPLAY PANEL

    labellabel

  • INGREDIENTS AND APPEARANCE
    CYCLEASE MENOPAUSE 
    arnica montana whole, black cohosh, nitroglycerin, lachesis muta venom, sanguinaria canadensis root tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-9082
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3) NITROGLYCERIN4 [hp_C]
    BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH4 [hp_C]
    LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM5 [hp_C]
    SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT4 [hp_C]
    ARNICA MONTANA WHOLE (UNII: O80TY208ZW) (ARNICA MONTANA WHOLE - UNII:O80TY208ZW) ARNICA MONTANA WHOLE4 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code Boiron
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0220-9082-0460 in 1 CARTON04/01/2020
    160 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/01/2020
    Labeler - Boiron (282560473)
    Registrant - Boiron Inc. (014892269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boiron282560473manufacture(0220-9082)