COLOCYNTHIS
- Manufacturer
- SEVENE USA
- Effective date
- 2025-02-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 02:32:04
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
ACTIVE INGREDIENT
HOMEOPATHIC DILUTION OF HPUS COLOCYNTHIS
TRADITIONALLY USED FOR:
Abdominal cramps, colic*
DOSAGE & ADMINISTRATION SECTION
Directions: (adults/children) Dissolve 5 pellets under the tongue once a day until symptoms are relieved or as directed by a physician.
USE
Condition listed above or as directed by a physician.
WARNINGS
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
Store at room temperature.
OTC - DO NOT USE SECTION
Do not use if pellet-dispenser seal is broken.
INACTIVE INGREDIENT
SUCROSE
QUESTIONS?
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
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 76472-4077-1 | 2025-02-11 | C162847 | 48780-1 | 2cef2736-99fd-d83d-e063-dadaa90ab31f | Sevene USA (as PLD) - COLOCYNTHIS 200CK (76472-4077) |
| 76472-4077-1 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-99fd-d83d-e063-dadaa90ab31f | Sevene USA (as PLD) - COLOCYNTHIS 200CK (76472-4077) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76472-4077-1 | COLOCYNTHIS200CK | 80 in 1 CYLINDER | PELLET | 80 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 76472-4077 | COLOCYNTHIS 200CK (COLOCYNTHIS) PELLET [SEVENE USA] | 4 | Current NDC, Legacy NDC, 1 package rows | 20250213_ed9cdba3-0567-6717-e053-2995a90ab3ec.zip |
Products#
Every source-derived product name is available through these pages.
- COLOCYNTHIS 200CK
- COLOCYNTHIS
- SUCROSE
- CITRULLUS COLOCYNTHIS FRUIT PULP
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 76472-4077 | 76472-4077-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SUCROSE | C151H8M554 | IACT |
| CITRULLUS COLOCYNTHIS FRUIT PULP | 23H32AOH17 | ACTIB |
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 |
|---|---|---|---|---|---|---|
| COLOCYNTHIS 200CK | COLOCYNTHIS | SEVENE USA | ed9cdba3-0567-6717-e053-2995a90ab3ec | 2025-02-11 | Warnings | 76472-4077-1 76472-4077 76472407701 2ddc3e44-4846-d734-e063-6394a90a682c ed9cdba3-0567-6717-e053-2995a90ab3ec |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
