FDA.reportPublic FDA data

COLOCYNTHIS

Manufacturer
SEVENE USA
Effective date
2024-01-24
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:25:52

Label at a glance#

ProductCOLOCYNTHIS 30C
Active ingredientCITRULLUS COLOCYNTHIS FRUIT PULP
Label structure12 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

HOMEOPATHIC DILUTION OF HPUS COLOCYNTHIS 30C

TRADITIONALLY USED FOR:

OTC - PURPOSE SECTION

Abdominal cramps, colic*

DOSAGE & ADMINISTRATION SECTION

Directions: (adults/children) Dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a physician.

USE

INDICATIONS & USAGE SECTION

Condition listed above or as directed by a physician.

WARNINGS

WARNINGS SECTION

Stop use and ask a physician if symptoms persist for more than 3 days or worsen.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTHER INFORMATION

OTHER SAFETY INFORMATION

Store at room temperature.

OTC - DO NOT USE SECTION

Do not use if pellet-dispenser seal is broken.

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

SUCROSE

QUESTIONS?

OTC - QUESTIONS SECTION

INFO@OLLOIS.COM * www.ollois.com * MADE IN FRANCE. NOT REVIEWED BY THE FDA AND NOT GUARANTEED TO BE EFFECTIVE. THIS HOMEOPATHIC DILUTION MAY NOT BE SUSEPTIBLE TO SCIENTIFIC MEASUREMENT.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Colocynthis 30c p1Colocynthis 30c p1Colocynthis 30c p2Colocynthis 30c p2

01b lbl01b lbl

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76472-4045-1COLOCYNTHIS30C80 in 1 CYLINDERPELLET804

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76472-4045COLOCYNTHIS 30C (COLOCYNTHIS) PELLET [SEVENE USA]4Current NDC, Legacy NDC, 1 package rows20240127_eeb54391-dbc0-e3cb-e053-2995a90a76f6.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76472-404576472-4045-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUCROSEC151H8M554IACT
CITRULLUS COLOCYNTHIS FRUIT PULP23H32AOH17ACTIB

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
COLOCYNTHIS 30CCOLOCYNTHISSEVENE USAeeb54391-dbc0-e3cb-e053-2995a90a76f62024-01-24WarningsExact identifier
ndc (package): 76472-4045-1
ndc (product): 76472-4045
ndc11 (package): 76472404501
spl id: 0fb95b48-668d-af90-e063-6394a90a859f
spl set id: eeb54391-dbc0-e3cb-e053-2995a90a76f6

Reported adverse events (FAERS/openFDA)#

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