MedPath

Sepia 30c

Sevene USA (as PLD) - Sepia 30c (76472-1161)

Approved
Approval ID

5730f482-481b-4d81-906c-af85e48aa574

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 22, 2025

Manufacturers
FDA

SEVENE USA

DUNS: 969332936

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

SEPIA OFFICINALIS JUICE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code76472-1161
Product Classification
G
Generic Name
SEPIA OFFICINALIS JUICE
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateMay 22, 2025
FDA Product Classification

INGREDIENTS (2)

SUCROSEInactive
Code: C151H8M554
Classification: IACT
SEPIA OFFICINALIS JUICEActive
Quantity: 30 [hp_C] in 1 1
Code: QDL83WN8C2
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/7/2017

sepia 30c p1sepia 30c p2sepia 30c p3

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 6/7/2017

USE:

Condition listed above or as directed by a physician.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 6/7/2017

ACTIVE INGREDIENT:

HOMEOPATHIC DILUTION OF HPUS Sepia 30c.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 3/6/2018

TRADITIONALLY USE FOR:

Menstrual symptoms* - Moodiness*

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 6/7/2017

DIRECTIONS:

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

WARNINGS SECTION

LOINC: 34071-1Updated: 6/7/2017

WARNINGS:

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 11/8/2011

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 11/16/2013

Keep out of reach of children.

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 6/7/2017

OTHER INFORMATION:

Store at room temperature.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 11/8/2011

Do not use if pellet-dispenser seal is broken.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 6/7/2017

INACTIVE INGREDIENTS:

Sucrose.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 3/6/2018

QUESTIONS?

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

RECENT MAJOR CHANGES SECTION

LOINC: 43683-2Updated: 6/13/2021

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Sepia 30c - FDA Drug Approval Details