Cyclease Menopause

Manufacturer
Boiron | Boiron Inc.
Effective date
2023-08-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:22:02

Label at a glance#

ProductCyclease Menopause
Active ingredientNITROGLYCERIN, BLACK COHOSH, LACHESIS MUTA VENOM, SANGUINARIA CANADENSIS ROOT, ARNICA MONTANA WHOLE
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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.

OTC - PURPOSE SECTION

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 SECTION

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 SECTION

Warnings

OTC - STOP USE SECTION

Stop use and ask a doctor if symptoms persist or worsen.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 SECTION

lactose, magnesium stearate, sucrose

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabellabellabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7480e90b-004b-ebe4-2243-4f2fefdd9e78Product name220260128
3f158398-73f2-4b90-47d1-5c60e8719a98Product name920250721
ca6149a6-ded3-9f17-6c41-3e88f2c0c9c0Product name220250117
00358076-c817-430b-b924-11d717dc307cProduct name120160718
669af5aa-14f3-3df7-f100-5f580ffd43c1Product name120140508
6ff3bab7-2dce-8bea-d7ce-54687f0c01fbProduct name120140508
8bb82a1c-d0d0-fc27-011f-172e545f0382Product name120140508
cb03406d-e223-80bb-67d8-be80f9b6a4f2Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0220-9082-042023-08-16C16284748780-1f386c64a-3b3e-0266-e053-dadaa90a7c1aCyclease Menopause
0220-9082-042023-01-30C16284748780-1f386c64a-3b3e-0266-e053-dadaa90a7c1aCyclease Menopause

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-9082-04Cyclease Menopause60 in 1 BLISTER PACKTABLET603
0220-9082-04Cyclease Menopause60 in 1 CARTONTABLET603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-9082CYCLEASE MENOPAUSE (ARNICA MONTANA WHOLE, BLACK COHOSH, NITROGLYCERIN, LACHESIS MUTA VENOM, SANGUINARIA CANADENSIS ROOT) TABLET [BOIRON]3Current NDC, Legacy NDC, 2 package rows20230817_a227e8d8-27a3-592f-e053-2a95a90ab31c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0220-90820220-9082-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cyclease MenopauseARNICA MONTANA WHOLE, BLACK COHOSH, NITROGLYCERIN, LACHESIS MUTA VENOM, SANGUINARIA CANADENSIS ROOTBoirona227e8d8-27a3-592f-e053-2a95a90ab31c2023-08-16WarningsExact identifier
ndc (package): 0220-9082-04
ndc (product): 0220-9082
ndc11 (package): 00220908204
spl id: 030b038f-d916-dc07-e063-6394a90a6e5e
spl set id: a227e8d8-27a3-592f-e053-2a95a90ab31c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.