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Histaminum hydrochloricum 30C - 3-Pack

Approved
Approval ID

31f094f5-00de-4e42-e063-6394a90a0fb6

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 15, 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.

Histaminum hydrochloricum

PRODUCT DETAILS

NDC Product Code76472-5003
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationSUBLINGUAL
Effective DateMay 15, 2025
Generic NameHistaminum hydrochloricum

INGREDIENTS (2)

HISTAMINE DIHYDROCHLORIDEActive
Quantity: 30 [hp_C] in 1 1
Code: 3POA0Q644U
Classification: ACTIB
SUCROSEInactive
Code: C151H8M554
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/15/2025

PRINCIPAL DISPLAY PANEL

HISTAMINUM HYDROCHLORICUM 30C 3P P1HISTAMINUM HYDROCHLORICUM 30C 3P P2HISTAMINUM HYDROCHLORICUM 30C 3P P3ETUI HISTAMINUM HYDROCHLORICUM 30C 3P P1ETUI HISTAMINUM HYDROCHLORICUM 30C 3P P2

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/15/2025

TRADITIONALLY USED FOR

Mild allergic reactions (coughing, sneezing, watery eyes)*

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

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 5/15/2025

DO NOT USE

Do not use if pellet-dispenser seal is broken.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/15/2025

INACTIVE INGREDIENTS

Sucrose.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/15/2025

ACTIVE INGREDIENT

HOMEOPATHIC DILUTION OF HISTAMINUM HYDROCHLORICUM 30c

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/15/2025

DIRECTIONS

(adults/children) Dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a physician.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/15/2025

USE

Condition listed above or as directed by a physician.

WARNINGS SECTION

LOINC: 34071-1Updated: 5/15/2025

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: 5/15/2025

PREGNANCY OR BREAST FEEDING

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/15/2025

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 5/15/2025

OTHER INFORMATION

Store at room temperature.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/15/2025

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.

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Histaminum hydrochloricum 30C - 3-Pack - FDA Drug Approval Details