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#
Contacts and useful links#
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
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 7480e90b-004b-ebe4-2243-4f2fefdd9e78 | Product name | 2 | 20260128 |
| 3f158398-73f2-4b90-47d1-5c60e8719a98 | Product name | 9 | 20250721 |
| ca6149a6-ded3-9f17-6c41-3e88f2c0c9c0 | Product name | 2 | 20250117 |
| 00358076-c817-430b-b924-11d717dc307c | Product name | 1 | 20160718 |
| 669af5aa-14f3-3df7-f100-5f580ffd43c1 | Product name | 1 | 20140508 |
| 6ff3bab7-2dce-8bea-d7ce-54687f0c01fb | Product name | 1 | 20140508 |
| 8bb82a1c-d0d0-fc27-011f-172e545f0382 | Product name | 1 | 20140508 |
| cb03406d-e223-80bb-67d8-be80f9b6a4f2 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0220-9082-04 | 2023-08-16 | C162847 | 48780-1 | f386c64a-3b3e-0266-e053-dadaa90a7c1a | Cyclease Menopause |
| 0220-9082-04 | 2023-01-30 | C162847 | 48780-1 | f386c64a-3b3e-0266-e053-dadaa90a7c1a | Cyclease Menopause |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0220-9082-04 | Cyclease Menopause | 60 in 1 BLISTER PACK | TABLET | 60 | 3 | |
| 0220-9082-04 | Cyclease Menopause | 60 in 1 CARTON | TABLET | 60 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0220-9082 | CYCLEASE MENOPAUSE (ARNICA MONTANA WHOLE, BLACK COHOSH, NITROGLYCERIN, LACHESIS MUTA VENOM, SANGUINARIA CANADENSIS ROOT) TABLET [BOIRON] | 3 | Current NDC, Legacy NDC, 2 package rows | 20230817_a227e8d8-27a3-592f-e053-2a95a90ab31c.zip |
Products#
Every source-derived product name is available through these pages.
- Cyclease Menopause
- ARNICA MONTANA WHOLE, BLACK COHOSH, NITROGLYCERIN, LACHESIS MUTA VENOM, SANGUINARIA CANADENSIS ROOT
- NITROGLYCERIN
- LACTOSE, UNSPECIFIED FORM
- MAGNESIUM STEARATE
- BLACK COHOSH
- LACHESIS MUTA VENOM
- SANGUINARIA CANADENSIS ROOT
- ARNICA MONTANA WHOLE
- SUCROSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0220-9082 | 0220-9082-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| NITROGLYCERIN | G59M7S0WS3 | ACTIB |
| LACTOSE, UNSPECIFIED FORM | J2B2A4N98G | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| BLACK COHOSH | K73E24S6X9 | ACTIB |
| LACHESIS MUTA VENOM | VSW71SS07I | ACTIB |
| SANGUINARIA CANADENSIS ROOT | N9288CD508 | ACTIB |
| ARNICA MONTANA WHOLE | O80TY208ZW | ACTIB |
| SUCROSE | C151H8M554 | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Cyclease Menopause | ARNICA MONTANA WHOLE, BLACK COHOSH, NITROGLYCERIN, LACHESIS MUTA VENOM, SANGUINARIA CANADENSIS ROOT | Boiron | a227e8d8-27a3-592f-e053-2a95a90ab31c | 2023-08-16 | Warnings | 0220-9082-04 0220-9082 00220908204 030b038f-d916-dc07-e063-6394a90a6e5e a227e8d8-27a3-592f-e053-2a95a90ab31c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

