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Spongia Tosta

Sevene USA (as PLD) - Spongia Tosta 30c (76472-1163)

Approved
Approval ID

d10e8c2a-0c3a-4946-b5b1-3c2decd48863

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.

SPONGIA OFFICINALIS SKELETON, ROASTED

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code76472-1163
Product Classification
G
Generic Name
SPONGIA OFFICINALIS SKELETON, ROASTED
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateMay 22, 2025
FDA Product Classification

INGREDIENTS (2)

SUCROSEInactive
Code: C151H8M554
Classification: IACT
SPONGIA OFFICINALIS SKELETON, ROASTEDActive
Quantity: 30 [hp_C] in 1 1
Code: 1PIP394IID
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 2/10/2017

spongia 30c p1spongia 30c p2spongia 30c p3

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 11/30/2011

Breathing difficulties associated with cough, croup, asthma.

use: Condition listed above or as directed by a physician.

WARNINGS SECTION

LOINC: 34071-1Updated: 3/6/2018

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: 11/30/2011

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 3/6/2018

ACTIVE INGREDIENT:

HOMEOPATHIC DILUTION OF HPUS Spongia Tosta 30c.

OTC - PURPOSE SECTION

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

TRADITIONALLY USE FOR:

Breathing difficulties associated with barking cough*

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 3/6/2018

DIRECTIONS:

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 11/30/2011

Keep out of reach of children.

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 3/6/2018

OTHER INFORMATION:

Store at room temperature.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 11/30/2011

Do not use if pellet-dispenser seal is broken.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 3/6/2018

INACTIVE INGREDIENT:

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.

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