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Calcarea Carbonic

Sevene USA (as PLD) - CALCAREA CARBONICA 200CK (76472-3008)

Approved
Approval ID

c8d4f3b3-166d-2411-e053-2a95a90abb4a

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.

OYSTER SHELL CALCIUM CARBONATE, CRUDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code76472-3008
Product Classification
G
Generic Name
OYSTER SHELL CALCIUM CARBONATE, CRUDE
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateMay 22, 2025
FDA Product Classification

INGREDIENTS (2)

SUCROSEInactive
Code: C151H8M554
Classification: IACT
OYSTER SHELL CALCIUM CARBONATE, CRUDEActive
Quantity: 200 [kp_C] in 1 1
Code: 2E32821G6I
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 2/21/2018

calcarea carbonica 200k p1calcarea carbonica 200k p2calcarea carbonica 200k p3

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 2/21/2018

USE

Condition listed above or as directed by a physician.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 2/21/2018

ACTIVE INGREDIENT

HOMEOPATHIC DILUTION OF HPUS CALCAREA CARBONICA 200ck** C, K, CK, AND X ARE HOMEOPATHIC DILUTIONS

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 2/21/2018

TRADITIONALLY USED FOR:

Late dentition & walking - Cradle cap*

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 11/22/2011

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: 2/21/2018

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: 11/22/2011

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 11/22/2011

Keep out of reach of children.

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 2/21/2018

OTHER INFORMATION

Store at room temperature.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 11/22/2011

Do not use if pellet-dispenser seal is broken.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 2/21/2018

INACTIVE INGREDIENT

SUCROSE

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 2/21/2018

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.

RECENT MAJOR CHANGES SECTION

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

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Calcarea Carbonic - FDA Drug Approval Details