MedPath

BM Calcium sulfide Hepar sulf (Calc Sulf)

BM Calcium sulfide Hepar sulf (Calc Sulf)

Approved
Approval ID

38039347-a63d-d54d-e063-6294a90a9f8b

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 20, 2025

Manufacturers
FDA

BM Private Limited

DUNS: 645599762

Products 1

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

Calcium Sulfide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code85816-1030
Product Classification
G
Generic Name
Calcium Sulfide
Product Specifications
Route of AdministrationORAL
Effective DateJune 20, 2025
FDA Product Classification

INGREDIENTS (3)

CALCIUM SULFIDEActive
Quantity: 6 [hp_X] in 60 mg
Code: 1MBW07J51Q
Classification: ACTIB
LACTOSEInactive
Quantity: 58.75 mg in 60 mg
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Quantity: 1.2 mg in 60 mg
Code: 70097M6I30
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/1/2025

Calcium sulfide 6X.jpgEntire package

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 6/1/2025

Uses
See the leaflet enclosed for detail.

CONTRAINDICATIONS SECTION

LOINC: 34070-3Updated: 6/1/2025

Contra-indications:
Traditional biochemic remedy do not interact with other remedies, herbs, or other supplements.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 6/1/2025

Directions:
Adult: Four tablets three times a day.
Ages below 12: half of the same or as prescribed by a homeopathic physician.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 6/1/2025

Inactive ingredients: Lactose; MAGNESIUM STEARATE

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 6/1/2025

Calcium Sulfide

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 6/1/2025

Uses
See the leaflet enclosed for detail.

WARNINGS SECTION

LOINC: 34071-1Updated: 6/1/2025

Warnings and Storage:
Ask a professional before use if pregnant or breastfeeding or if you have severe symptoms. Keep away from children. If you have a reaction to this product that is not positive, discontinue use. Store in a cool and dry place.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 6/1/2025

Warnings and Storage:
Ask a professional before use if pregnant or breastfeeding or if you have severe symptoms. Keep away from children. If you have a reaction to this product that is not positive, discontinue use. Store in a cool and dry place.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

BM Calcium sulfide Hepar sulf (Calc Sulf) - FDA Drug Approval Details