FDA.reportPublic FDA data

Menstrual Cramps and Irregularities

Manufacturer
King Bio Inc.
Effective date
2018-04-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:09:19

Label at a glance#

ProductMenstrual Cramps and Irregularities
Active ingredientSELENICEREUS GRANDIFLORUS STEM, CAULOPHYLLUM THALICTROIDES ROOT, MATRICARIA RECUTITA, BLACK COHOSH, CITRULLUS COLOCYNTHIS FRUIT PULP, IPECAC, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SEPIA OFFICINALIS JUICE, VIBURNUM OPULUS BARK, ZANTHOXYLUM AMERICANUM BARK
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts​__________________________________________________________________________________________________________

HPUS active ingredients: Cactus, Caulophyllum, Chamomilla, Cimicifuga, Colocynthis, Ipecac, Mag phos, Sepia, Viburnum op, Xanthoxylum. Equal volumes of each ingredient in 10X, 30X, 1LM potencies.

INDICATIONS & USAGE SECTION

Uses ​for temporary relief of symptoms: cramps, aches and pains, abdominal bloating, irregular periods, menstrual headache, heavy or gushing menstruation, backache, lack of menstrual flow.

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Bio-Energetically Enhanced™ pure water, Carya ovata bark extract, citrus extract, Lonicera japonica (honeysuckle), polylysine, steviol glycosides.

WARNINGS SECTION

Warnings

  • Stop use and ask a doctor if symptoms persist or worsen.
  • If pregnant or breast-feeding, ask a healthcare professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Initially, depress pump until primed.
  • Spray one dose directly into mouth.
  • Ages 12 and up: 3 sprays 3 times per day.

OTHER SAFETY INFORMATION

Tamper resistant for your protection. Use only if safety seal is intact.

OTC - PURPOSE SECTION

Uses for temporary relief of symptoms:

  • cramps
  • aches and pains
  • abdominal bloating
  • irregular periods
  • menstrual headache
  • heavy or gushing menstruation,
  • backache
  • lack of menstrual flow

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

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
57955-5004-22020-01-31C16284748780-19d75b9d1-018c-f424-e053-dadaa90a57ceMenstrual Cramps and Irregularities

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57955-5004-2Menstrual Cramps and Irregularities59 mL in 1 BOTTLE, SPRAYLIQUID592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57955-5004MENSTRUAL CRAMPS AND IRREGULARITIES (CACTUS, CAULOPHYLLUM, CHAMOMILLA, CIMICIFUGA, COLOCYNTHIS, IPECAC, MAG PHOS, SEPIA, VIBURNUM OP, XANTHOXYLUM) LIQUID [KING BIO INC.]2Legacy NDC, 1 package rows20180411_3d7aa2e1-6e6b-4d9d-9fbc-96e30d1564a3.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57955-500457955-5004-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
SELENICEREUS GRANDIFLORUS STEM7114SV0MYKACTIB
CAULOPHYLLUM THALICTROIDES ROOTJTJ6HH6YEHACTIB
MATRICARIA RECUTITAG0R4UBI2ZZACTIB
BLACK COHOSHK73E24S6X9ACTIB
CITRULLUS COLOCYNTHIS FRUIT PULP23H32AOH17ACTIB
IPECAC62I3C8233LACTIB
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEHF539G9L3QACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
VIBURNUM OPULUS BARKT1UG6H6805ACTIB
ZANTHOXYLUM AMERICANUM BARKA4KL1HMZ7TACTIB
WATER059QF0KO0RIACT
CARYA OVATA BARKX765CF609LIACT
CITRUS BIOFLAVONOIDSBD70459I50IACT
LONICERA JAPONICA FLOWER4465L2WS4YIACT
POLYEPSILON-LYSINE (4000 MW)WB0M8X4TWRIACT
REBAUDIOSIDE AB3FUD0528FIACT

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
5bb45feb-f7a0-438d-bb1e-43edca584f873d7aa2e1-6e6b-4d9d-9fbc-96e30d1564a32018-04-10WarningsExact identifier
spl id: 5bb45feb-f7a0-438d-bb1e-43edca584f87
spl set id: 3d7aa2e1-6e6b-4d9d-9fbc-96e30d1564a3

Reported adverse events (FAERS/openFDA)#

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