Histamine

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2024-08-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:27:52

Label at a glance#

ProductHistamine 6X
Active ingredientHISTAMINE DIHYDROCHLORIDE
Label structure9 sections

Dosage and administration

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION


Histaminum Hydrochloricum 6X.

PURPOSE:

OTC - PURPOSE SECTION

For temporary relief of sinus congestion, hives, mood swings, fatigue, and chest congestion with constriction.

WARNINGS:

WARNINGS SECTION

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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing.

Store in cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

PURPOSE:

INDICATIONS & USAGE SECTION

For temporary relief of sinus congestion, hives, mood swings, fatigue, and chest congestion with constriction.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized Water, 25% Ethanol

QUESTIONS:

OTC - QUESTIONS SECTION

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BioActive Nutritional

HISTAMINE 6X

HOMEOPATHIC

1 FL OZ (30 ml)

Histamine 6XHistamine 6X

Histamine 6XHistamine 6X

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0309-12024-08-30C16284748780-19d75b9d0-9fcd-f424-e053-dadaa90a57ceDRUG FACTS:
43857-0309-12022-01-28C16284748780-19d75b9d0-9fcd-f424-e053-dadaa90a57ceDRUG FACTS:
43857-0309-12020-05-18C16284748780-19d75b9d0-9fcd-f424-e053-dadaa90a57ceDRUG FACTS:
43857-0309-12020-01-31C16284748780-19d75b9d0-9fcd-f424-e053-dadaa90a57ceDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0309-1Histamine6X30 mL in 1 BOTTLE, DROPPERLIQUID304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0309HISTAMINE 6X (HISTAMINUM HYDROCHLORICUM) LIQUID [BIOACTIVE NUTRITIONAL, INC.]4Current NDC, Legacy NDC, 1 package rows20240831_ccac734f-0596-476d-8a17-10c222b460fb.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HISTAMINE DIHYDROCHLORIDEACTIVE INGREDIENT3POA0Q644U1
HISTAMINEACTIVE MOIETY820484N8I31
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-030943857-0309-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
HISTAMINE DIHYDROCHLORIDE3POA0Q644UACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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
Histamine 6XHISTAMINUM HYDROCHLORICUMBioActive Nutritional, Inc.ccac734f-0596-476d-8a17-10c222b460fb2024-08-30WarningsExact identifier
ndc (package): 43857-0309-1
ndc (product): 43857-0309
ndc11 (package): 43857030901
spl id: e8c0c38c-3e6c-4c71-9e19-5fa109375b82
spl set id: ccac734f-0596-476d-8a17-10c222b460fb

Reported adverse events (FAERS/openFDA)#

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