MedPath

Bestmade Natural Products Hepar Sulphuris

HEPAR SULPHURIS 30C

Approved
Approval ID

29a45852-3870-d044-e063-6394a90af82b

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 27, 2025

Manufacturers
FDA

Bestmade Natural Products

DUNS: 047124582

Products 1

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

Hepar Sulphuris

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code82969-5057
Product Classification
G
Generic Name
Hepar Sulphuris
Product Specifications
Route of AdministrationORAL
Effective DateMay 27, 2025
FDA Product Classification

INGREDIENTS (3)

CALCIUM SULFIDEActive
Quantity: 30 [hp_C] in 30 [hp_C]
Code: 1MBW07J51Q
Classification: ACTIB
LACTOSEInactive
Quantity: 30 [hp_C] in 30 [hp_C]
Code: J2B2A4N98G
Classification: IACT
SUCROSEInactive
Quantity: 30 [hp_C] in 30 [hp_C]
Code: C151H8M554
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 1/1/2015

Entire package label

Hepar Sulph

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 1/1/2015

Best for

Temporarily relieves occasional mouth and gum discomfort, sore throat, and swollen lymphatic glands.*

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 1/1/2015

How to Use

Take with water 3-4 times a day. Ages 12 or older, 5 Pellets, Ages 12-2, 3 Pellets, Ages below 2, consult your Doctor.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 1/1/2015

Best for

Temporarily relieves occasional mouth and gum discomfort, sore throat, and swollen lymphatic glands.*

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 1/1/2015

Ingredients

Inactive: Sucrose/Lactose Pellets base to Preserve Remedy

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 1/1/2015

Active Ingredients: Hepar Sulphuris Calcareum [HPUS] 30c potency

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 1/1/2015

Warnings:

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

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE NOT FDA EVALUATED.
This product is not intended to diagnose, treat, cure, or prevent any disease.

WARNINGS SECTION

LOINC: 34071-1Updated: 1/1/2015

Warnings:

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

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE NOT FDA EVALUATED.
This product is not intended to diagnose, treat, cure, or prevent any disease.

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Bestmade Natural Products Hepar Sulphuris - FDA Drug Approval Details