CALCAREA SULPHURICA

Manufacturer: SEVENE USA
Effective date: 2025-02-11
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-06-01 02:32:06

Label at a glance#

ProductCALCAREA SULPHURICA 6X

Active ingredientCALCIUM SULFATE ANHYDROUS

Label structure11 sections

Indications and uses

Pustular acne, itchy and irritated skin, and joint health**. **C, K, CK & X are homeopathic dilutions.

Dosage and administration

(Adults/Children) Dissolve 5 pellets under the tongue three times a day until symptoms are relieved or as directed by a doctor.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT:

OTC - ACTIVE INGREDIENT SECTION

CALCAREA SULPHURICA 6X**

TRADITIONALLY USED FOR TEMPORARY RELIEF FROM:

OTC - PURPOSE SECTION

Pustular acne, itchy and irritated skin, and joint health*

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

(Adults/Children) Dissolve 5 pellets under the tongue three times a day until symptoms are relieved or as directed by a doctor.

USES:

INDICATIONS & USAGE SECTION

Pustular acne, itchy and irritated skin, and joint health**.

**C, K, CK & X are homeopathic dilutions.

WARNINGS

WARNINGS SECTION

Stop use and ask a doctor 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.
In case of overdose, get medical help.

OTHER INFORMATION:

OTHER SAFETY INFORMATION

Store at room temperature.
Do not use if tamper-evidence seal is broken.
Organic verified by Alpes Control 2021/A03M216K/1.

INACTIVE INGREDIENT:

INACTIVE INGREDIENT SECTION

ORGANIC SUCROSE

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

Email us at: info@ollois.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_Calcarea Sulphurica_6X_80ct

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76472-4090-1	2025-02-11	C162847	48780-1	2cef2736-9179-d83d-e063-dadaa90ab31f	SEVENE USA (as PLD) - CALCAREA SULPHURICA 6X (76472-4090)
76472-4090-1	2025-01-30	C162847	48780-1	2cef2736-9179-d83d-e063-dadaa90ab31f	SEVENE USA (as PLD) - CALCAREA SULPHURICA 6X (76472-4090)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76472-4090-1	CALCAREA SULPHURICA6X	80 in 1 CYLINDER	PELLET	80		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76472-4090	CALCAREA SULPHURICA 6X (CALCAREA SULPHURICA) PELLET [SEVENE USA]	4	Current NDC, 1 package rows	20250213_ff0d77e8-b113-1a32-e053-6294a90a9fcc.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

CALCAREA SULPHURICA 6X
CALCAREA SULPHURICA
SUCROSE
CALCIUM SULFATE ANHYDROUS
CALCIUM CATION

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
76472-4090	76472-4090-1

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
Name	UNII	Kind
SUCROSE	C151H8M554	IACT
CALCIUM SULFATE ANHYDROUS	E934B3V59H	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CALCAREA SULPHURICA 6X	CALCAREA SULPHURICA	SEVENE USA	ff0d77e8-b113-1a32-e053-6294a90a9fcc	2025-02-11	Warnings	Exact identifier ndc (package): 76472-4090-1 ndc (product): 76472-4090 ndc11 (package): 76472409001 spl id: 2ddc269b-5443-d6b3-e063-6394a90a5f0a spl set id: ff0d77e8-b113-1a32-e053-6294a90a9fcc

Reported adverse events (FAERS/openFDA)#

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