FDA.reportPublic FDA data

Histaminum hydrochloricum 30C - 3-Pack

Manufacturer
SEVENE USA
Effective date
2025-05-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:33:51

Label at a glance#

ProductHistaminum hydrochloricum 30C - 3-Pack
Active ingredientHISTAMINE DIHYDROCHLORIDE
Label structure12 sections

Dosage and administration

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

HOMEOPATHIC DILUTION OF HISTAMINUM HYDROCHLORICUM 30c

TRADITIONALLY USED FOR

INDICATIONS & USAGE SECTION

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

*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 3 times a day until symptoms are relieved or as directed by a physician.

USE

OTC - PURPOSE SECTION

Condition listed above or as directed by a physician.

WARNINGS

WARNINGS SECTION

Stop use and ask a physician if symptoms persist for more than 3 days or worsen.

PREGNANCY OR BREAST FEEDING

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTHER INFORMATION

OTHER SAFETY INFORMATION

Store at room temperature.

DO NOT USE

OTC - DO NOT USE SECTION

Do not use if pellet-dispenser seal is broken.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Sucrose.

QUESTIONS?

OTC - QUESTIONS SECTION

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.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HISTAMINUM HYDROCHLORICUM 30C 3P P1HISTAMINUM HYDROCHLORICUM 30C 3P P1HISTAMINUM HYDROCHLORICUM 30C 3P P2HISTAMINUM HYDROCHLORICUM 30C 3P P2HISTAMINUM HYDROCHLORICUM 30C 3P P3HISTAMINUM HYDROCHLORICUM 30C 3P P3ETUI HISTAMINUM HYDROCHLORICUM 30C 3P P1ETUI HISTAMINUM HYDROCHLORICUM 30C 3P P1ETUI HISTAMINUM HYDROCHLORICUM 30C 3P P2ETUI HISTAMINUM HYDROCHLORICUM 30C 3P P2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76472-5003-1Histaminum hydrochloricum 30C - 3-Pack80 in 1 CYLINDERPELLET802
76472-5003-2Histaminum hydrochloricum 30C - 3-Pack3 in 1 BOXPELLET32

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76472-500376472-5003-1, 76472-5003-2

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
NameUNIIKind
HISTAMINE DIHYDROCHLORIDE3POA0Q644UACTIB
SUCROSEC151H8M554IACT

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Histaminum hydrochloricum 30C - 3-PackHISTAMINUM HYDROCHLORICUMSEVENE USA31f094f5-00de-4e42-e063-6394a90a0fb62025-05-15WarningsExact identifier
ndc (package): 76472-5003-2
ndc (package): 76472-5003-1
ndc (product): 76472-5003
ndc11 (package): 76472500301
ndc11 (package): 76472500302
spl id: 352cb7dd-6c7f-f081-e063-6294a90ac2f6
spl set id: 31f094f5-00de-4e42-e063-6394a90a0fb6

Reported adverse events (FAERS/openFDA)#

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