Histatone

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2024-10-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:28:24

Label at a glance#

ProductHistatone
Active ingredientGARLIC, BAPTISIA TINCTORIA ROOT, ECHINACEA ANGUSTIFOLIA WHOLE, ONION, AMBROSIA ARTEMISIIFOLIA WHOLE, ARSENIC TRIOXIDE, PHOSPHORUS, PULSATILLA PRATENSIS WHOLE, SOLIDAGO VIRGAUREA FLOWERING TOP
Label structure9 sections

Dosage and administration

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist, consult your health care professional. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

(in each drop): 16.62% of Allium Cepa 12X, Ambrosia Artemisiaefolia 12X, Arsenicum Album 12X, Phosphorus 12X, Pulsatilla (Pratensis) 12X, Solidago Virgaurea 12X; 0.10% of Allium Sativum 3X, Baptisia Tinctoria 3X, Echinacea (Angustifolia) 3X.

INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of hay fever, sinus, cough, bronchial irritation, itching and burning.**

**These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

WARNINGS:

WARNINGS SECTION

If pregnant or breast-feeding, ask a health 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 a 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

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist, consult your health care professional. Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

For temporary relief of hay fever, sinus, cough, bronchial irritation, itching and burning.**

**These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized water, 20% Ethanol

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. by Energique, Inc.

201 Apple Blvd

Woodbine, IA 51579 800.869.8078

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

HISTATONE

1 fl. oz. (30 ml)

HISTATONEHISTATONE

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0580-12024-10-25C16284748780-1f386c649-cf76-0266-e053-dadaa90a7c1aDRUG FACTS:
44911-0580-12023-01-30C16284748780-1f386c649-cf76-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0580-1Histatone30 mL in 1 BOTTLE, DROPPERLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0580HISTATONE (ALLIUM SATIVUM, BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SOLIDAGO VIRGAUREA) LIQUID [ENERGIQUE, INC.]2Current NDC, Legacy NDC, 1 package rows20241027_309fe946-8639-4c17-a939-06bffe6caa2d.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44911-058044911-0580-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

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
HistatoneALLIUM SATIVUM, BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SOLIDAGO VIRGAUREAEnergique, Inc.309fe946-8639-4c17-a939-06bffe6caa2d2024-10-25WarningsExact identifier
ndc (package): 44911-0580-1
ndc (product): 44911-0580
ndc11 (package): 44911058001
spl id: d701f94c-3c2d-421e-89ed-58237b458e95
spl set id: 309fe946-8639-4c17-a939-06bffe6caa2d

Reported adverse events (FAERS/openFDA)#

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