Label: CYCLEASE CRAMPS- black cohosh, citrullus colocynthis fruit pulp, esium phosphate, dibasic trihydrate 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 March 6, 2023

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  • ACTIVE INGREDIENT

    Cimicifuga racemosa 6C HPUS (0.8mg), Colcynthis 6C HPUS (0.8mg), Magnesia phosphorica 6C HPUS *0.8mg)

  • INDICATIONS & USAGE

    Temporarily relieves symptoms associated with menstrual cramps such as: discomfort, minor aches and pain

  • DO NOT USE

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

  • DOSAGE & ADMINISTRATION

    Adults and children 12 years of age and older: At the onset of symptoms, dissolve 2 tablets under the tongue. Wait 15 minutes, the repeat as needed every 15 minutes until symptoms are relieved. Not to exceed 12 doses per day.

    Children until 12 of age: Ask a doctor.

  • INACTIVE INGREDIENT

    Croscarmellose sodium, lactose, magnesium stearate

  • HOW SUPPLIED

    60 tablets

  • PURPOSE

    Cimicifuga racemosa 6C ...Relieves menstrual cramps with aches and pains radiating to the thighs

    Colcynthis 6C...Relieves menstrual cramps


    Magnesia phosphorica 6C... Relieves menstrual cramps improved by warmth

  • STORAGE AND HANDLING

    Store at 68-77 o F

  • 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

    *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.

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

  • PRINCIPAL DISPLAY PANEL

    labelbox

  • INGREDIENTS AND APPEARANCE
    CYCLEASE CRAMPS 
    black cohosh, citrullus colocynthis fruit pulp, esium phosphate, dibasic trihydrate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0220-9078
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH6 [hp_C]
    CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT PULP6 [hp_C]
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE6 [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:0220-9078-0460 in 1 BLISTER PACK; Type 0: Not a Combination Product07/08/1992
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/08/1992
    Labeler - Laboratoires Boiron (282560473)
    Registrant - Boiron Inc. (014892269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Boiron282560473manufacture(0220-9078)
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