MedPath

Belladonna 30X

Belladonna 30X - Granules

Approved
Approval ID

33628150-4483-e973-e063-6294a90a05d8

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 20, 2025

Manufacturers
FDA

Laboratoire Schmidt-Nagel Inc.

DUNS: 203869883

Products 1

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

Belladonna

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code73296-004
Product Classification
G
Generic Name
Belladonna
Product Specifications
Route of AdministrationSUBLINGUAL, ORAL
Effective DateMay 20, 2025
FDA Product Classification

INGREDIENTS (2)

SUGARCANEInactive
Code: 81H2R5AOH3
Classification: IACT
ATROPA BELLADONNAActive
Quantity: 30 [hp_X] in 1 g
Code: WQZ3G9PF0H
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 4/22/2025

Belladonna

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 4/17/2025

For reducing fever with perspiration, headache, and inflammation*

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 4/17/2025

Active ingredients HPUS: Each globule contains 1% Belladonna 30X

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 4/17/2025

For reducing fever with perspiration, headache, and inflammation*

WARNINGS SECTION

LOINC: 34071-1Updated: 4/17/2025

If symptoms worsen or persist for more than 7 days, consult a physician.

OTC - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 4/17/2025

If pregnant or breastfeeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 4/17/2025

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 4/17/2025

3 globules 3 times a day or as directed by a homeopath. Oral/Sublingual use.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 4/17/2025

Organic cane sugar globules.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 4/17/2025

1 (888) 290-8140 or schmidt-nagel.com

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 4/17/2025

Conservation: 15°C - 25°C

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 4/17/2025

*Claims based on traditional homeopathic practices, not accepted medical evidences. Not FDA evaluated.

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Belladonna 30X - FDA Drug Approval Details