Histastat Food

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2024-07-26
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:27:39

Label at a glance#

ProductHistastat Food
Active ingredientCHELIDONIUM MAJUS WHOLE, ECHINACEA ANGUSTIFOLIA WHOLE, GENTIANA LUTEA ROOT, ARSENIC TRIOXIDE, ACTIVATED CHARCOAL, LYCOPODIUM CLAVATUM SPORE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, PULSATILLA PRATENSIS WHOLE
Label structure9 sections

Indications and uses

May temporarily relieve digestive symptoms, such as: • indigestion with flatulence and bloating • loss of weight, associated with problem foods.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Dosage and administration

• Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a 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) Arsenicum Album 12X 16.62%, Carbo Vegetabilis 12X 16.62%, Lycopodium Clavatum 12X 16.62%, Nux Vomica 12X 16.62%, Phosphorus 12X 16.62%, Pulsatilla 12X 16.62%, Chelidonium Majus 3X 0.10%, Echinacea 3X 0.10%, Gentiana Lutea 3X 0.10%.

PURPOSE:

OTC - PURPOSE SECTION

Arsenicum Album – shortness of breath,** Carbo Vegetabilis - indigestion,** Lycopodium Clavatum - bloating,** Nux Vomica - nausea,** Phosphorus - itching,** Pulsatilla - hives,** Chelidonium Majus - headache,** Echinacea – nasal congestion,** Gentiana Lutea – diarrhea**

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

USES:

INDICATIONS & USAGE SECTION

May temporarily relieve digestive symptoms, such as:

• indigestion with flatulence and bloating • loss of weight, associated with problem foods.**

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

WARNINGS:

WARNINGS SECTION

Stop use and ask a doctor if symptoms persist for more than 2 days.

If pregnant or breastfeeding, 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

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.

• Consult a physician for use in children under 12 years of age.

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
HISTASTAT FOOD
1 fl. oz. (30 ml)

Histastat FoodHistastat Food

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
44911-0574-12024-07-26C16284748780-1f386c649-ced0-0266-e053-dadaa90a7c1aDRUG FACTS:
44911-0574-12023-01-30C16284748780-1f386c649-ced0-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0574-1Histastat Food30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0574HISTASTAT FOOD (CHELIDONIUM MAJUS, ECHINACEA (ANGUSTIFOLIA), GENTIANA LUTEA, ARSENICUM ALBUM, CARBO VEGETABILIS, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORUS, PULSATILLA (PRATENSIS)) LIQUID [ENERGIQUE, INC.]3Current NDC, Legacy NDC, 1 package rows20240727_e9d6b64f-9b20-422c-91f6-c26def4d53d0.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
44911-057444911-0574-1

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
Histastat FoodCHELIDONIUM MAJUS, ECHINACEA (ANGUSTIFOLIA), GENTIANA LUTEA, ARSENICUM ALBUM, CARBO VEGETABILIS, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORUS, PULSATILLA (PRATENSIS)Energique, Inc.e9d6b64f-9b20-422c-91f6-c26def4d53d02024-07-26WarningsExact identifier
ndc (package): 44911-0574-1
ndc (product): 44911-0574
ndc11 (package): 44911057401
spl id: 9c03c1ae-273c-4544-915d-87f16652ffdc
spl set id: e9d6b64f-9b20-422c-91f6-c26def4d53d0

Reported adverse events (FAERS/openFDA)#

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