FDA.reportPublic FDA data

Cyclease Cramp

Manufacturer
Laboratoires Boiron | Boiron Inc. | Boiron
Effective date
2023-03-06
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 02:20:25

Label at a glance#

ProductCyclease Cramps
Active ingredientBLACK COHOSH, CITRULLUS COLOCYNTHIS FRUIT PULP, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE
Label structure16 sections

Storage and handling

Store at 68-77 o F

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

INDICATIONS & USAGE SECTION

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

OTC - DO NOT USE SECTION

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

DOSAGE & ADMINISTRATION SECTION

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.

RECENT MAJOR CHANGES SECTION

INACTIVE INGREDIENT SECTION

Croscarmellose sodium, lactose, magnesium stearate

HOW SUPPLIED SECTION

60 tablets

OTC - PURPOSE SECTION

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 SECTION

Store at 68-77 o F

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

*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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabelboxbox

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0220-9078-042023-03-06C16284748780-1f386c649-9c61-0266-e053-dadaa90a7c1aCyclease Cramp
0220-9078-042023-01-30C16284748780-1f386c649-9c61-0266-e053-dadaa90a7c1aCyclease Cramp

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-9078-04Cyclease Cramps60 in 1 BLISTER PACKTABLET607

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-9078CYCLEASE CRAMPS (BLACK COHOSH, CITRULLUS COLOCYNTHIS FRUIT PULP, ESIUM PHOSPHATE, DIBASIC TRIHYDRATE) TABLET [LABORATOIRES BOIRON]7Current NDC, Legacy NDC, 1 package rows20230307_39c20cb2-79c4-4775-b3a9-55cfa67fb743.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BLACK COHOSHACTIVE INGREDIENTK73E24S6X93
CITRULLUS COLOCYNTHIS FRUIT PULPACTIVE INGREDIENT23H32AOH173
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEACTIVE INGREDIENTHF539G9L3Q3
BLACK COHOSHACTIVE MOIETYK73E24S6X93
CITRULLUS COLOCYNTHIS FRUIT PULPACTIVE MOIETY23H32AOH173
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY8383
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
0220-90780220-9078-04

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
BLACK COHOSHK73E24S6X9ACTIB
CITRULLUS COLOCYNTHIS FRUIT PULP23H32AOH17ACTIB
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEHF539G9L3QACTIB

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
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
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 CrampsBLACK COHOSH, CITRULLUS COLOCYNTHIS FRUIT PULP, ESIUM PHOSPHATE, DIBASIC TRIHYDRATELaboratoires Boiron39c20cb2-79c4-4775-b3a9-55cfa67fb7432023-03-06WarningsExact identifier
ndc (package): 0220-9078-04
ndc (product): 0220-9078
ndc11 (package): 00220907804
spl id: f63ce25e-71a7-5139-e053-2a95a90af330
spl set id: 39c20cb2-79c4-4775-b3a9-55cfa67fb743

Reported adverse events (FAERS/openFDA)#

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