FDA.reportPublic FDA data

Cyclease PMS

Manufacturer
Laboratoires Boiron | Boiron Inc. | Boiron
Effective date
2023-05-30
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 02:21:18

Label at a glance#

ProductCyclease PMS
Active ingredientESTRONE, SODIUM CHLORIDE, SEPIA OFFICINALIS JUICE
Label structure16 sections

Storage and handling

Store at 68-77 o F (30 o C)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Folliculinum 15C HPUS (0.8mg), Natrum muriaticum 12C HPUS (0.8mg), Sepia 12C HPUS (0.8mg)

INDICATIONS & USAGE SECTION

Temporary relieves premenstrual symptoms such as: bloating, water retention, minor aches, lower back pain, discomfort, emotional changes, irritability

OTC - DO NOT USE SECTION

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

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older: Dissolve 2 tablets in the mouth morning and evening until symptoms are relieved.
Children under 12 years of age: Not recommended

INACTIVE INGREDIENT SECTION

Croscarmellose sodium, lactose, magnesium stearate

HOW SUPPLIED SECTION

60 meltaway tablets

OTC - PURPOSE SECTION

Folliculinum 15C ...Relieves discomfort and aches associated with PMS
Natrum muriaticum 12C ...Relieves water retention and irritability
Sepia 12C...Relieves bloating and lower back pain.

STORAGE AND HANDLING SECTION

Store at 68-77 o F (30 oC)

OTC - QUESTIONS SECTION

Questions, Comments

Boironusa.com

info@boironusa.com

1-800-BOIRON-1

(1-800-264-7661)

Distributed by Boiron, Inc.

Newtown Square, PA 19073

OTC - STOP USE SECTION

Stop use and ask a doctor if symptoms persist for more than 7 days or worsen.

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

DRUG INTERACTIONS SECTION

Safe - no side effects - no drug interactions - works naturally with your body

WARNINGS SECTION

Enter section text here

SPL UNCLASSIFIED SECTION

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

*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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabelboxbox

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
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362d7abb-94e6-4c60-9a58-266894157713Product name120231023
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dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
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ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0220-9081-042023-05-30C16284748780-1f386c64a-1c14-0266-e053-dadaa90a7c1aCyclease PMS
0220-9081-042023-01-30C16284748780-1f386c64a-1c14-0266-e053-dadaa90a7c1aCyclease PMS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-9081-04Cyclease PMS60 in 1 BLISTER PACKTABLET606

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-9081CYCLEASE PMS (ESTRONE, SODIUM CHLORIDE, SEPIA OFFICINALIS JUICE) TABLET [LABORATOIRES BOIRON]6Current NDC, Legacy NDC, 1 package rows20230531_09ff0633-2992-4aba-96ed-45a69f3ee589.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ESTRONEACTIVE INGREDIENT2DI9HA706A3
SEPIA OFFICINALIS JUICEACTIVE INGREDIENTQDL83WN8C23
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8X3
ESTRONEACTIVE MOIETY2DI9HA706A3
SEPIA OFFICINALIS JUICEACTIVE MOIETYQDL83WN8C23
SODIUM CATIONACTIVE MOIETYLYR4M0NH373
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH483
LactoseINACTIVE INGREDIENTJ2B2A4N98G3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I303

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0220-90810220-9081-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
CROSCARMELLOSE SODIUMM28OL1HH48IACT
LACTOSEJ2B2A4N98GIACT
MAGNESIUM STEARATE70097M6I30IACT
ESTRONE2DI9HA706AACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 6 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
LactoseLACTOSEJ2B2A4N98GTABLET / ORAL2500 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
LactoseLACTOSEJ2B2A4N98GTABLET / ORAL2500 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET / ORAL736 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET / ORAL736 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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 PMSESTRONE, SODIUM CHLORIDE, SEPIA OFFICINALIS JUICELaboratoires Boiron09ff0633-2992-4aba-96ed-45a69f3ee5892023-05-30WarningsExact identifier
ndc (package): 0220-9081-04
ndc (product): 0220-9081
ndc11 (package): 00220908104
spl id: fcea41e7-b1a6-8718-e053-6294a90a117a
spl set id: 09ff0633-2992-4aba-96ed-45a69f3ee589

Reported adverse events (FAERS/openFDA)#

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