Label: CYCLEASE MENOPAUSE- arnica montana whole, black cohosh, nitroglycerin, lachesis muta venom, sanguinaria canadensis root tablet
- NDC Code(s): 0220-9082-04
- Packager: Boiron
- 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.
Updated April 1, 2021
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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.
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
temporarily relieves symptoms associated with perimenopause and menopause such as:
- hot flashes
- red, blotchy or flushed face
- night sweats
- mood changes
- occasional sleeplessness
temporarily reduces the intensity and frequency of hot flashes associated with perimenopause and menopause
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
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
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
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
arnica montana whole, black cohosh, nitroglycerin, lachesis muta venom, sanguinaria canadensis root tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0220-9082 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3) NITROGLYCERIN 4 [hp_C] BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH 4 [hp_C] LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM 5 [hp_C] SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT 4 [hp_C] ARNICA MONTANA WHOLE (UNII: O80TY208ZW) (ARNICA MONTANA WHOLE - UNII:O80TY208ZW) ARNICA MONTANA WHOLE 4 [hp_C] Inactive Ingredients Ingredient Name Strength LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) SUCROSE (UNII: C151H8M554) Product Characteristics Color white Score no score Shape ROUND Size 9mm Flavor Imprint Code Boiron Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0220-9082-04 60 in 1 CARTON 04/01/2020 1 60 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 04/01/2020 Labeler - Boiron (282560473) Registrant - Boiron Inc. (014892269) Establishment Name Address ID/FEI Business Operations Boiron 282560473 manufacture(0220-9082)