FDA.reportPublic FDA data

Additivestat

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2024-07-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:27:33

Label at a glance#

ProductAdditivestat
Active ingredientTRIFOLIUM PRATENSE FLOWER, KEROSENE, PHYTOLACCA AMERICANA ROOT, ARSENIC TRIOXIDE, CHELIDONIUM MAJUS WHOLE, LYCOPODIUM CLAVATUM SPORE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORIC ACID, PHOSPHORUS, NITRIC ACID
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 for more than 7 days, 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): 11.10% of Arsenicum Album 12X, Chelidonium Majus 12X, Lycopodium Clavatum 12X, Nitricum Acidum 12X, Nux Vomica 12X, Petroleum 6X, Phosphorus 12X, Phosphoricum Acidum 12X, Phytolacca Decandra 6X; 0.10% of Trifolium Pratense 3X.

INDICATIONS:

OTC - PURPOSE SECTION

May temporarily relieve debility, exhaustion after slight exertion, and nausea.**

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

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

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 for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

May temporarily relieve debility, exhaustion after slight exertion, and nausea.**

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

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

ADDITIVESTAT

1 fl. OZ. (30 ml)

ADDITIVESTATADDITIVESTAT

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
44911-0630-12024-07-16C16284748780-11030e365-3321-111a-e063-dadaa90a10e2DRUG FACTS:
44911-0630-12024-01-30C16284748780-11030e365-3321-111a-e063-dadaa90a10e2DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0630-1Additivestat30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0630ADDITIVESTAT (TRIFOLIUM PRATENSE, PETROLEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, NITRICUM ACIDUM) LIQUID [ENERGIQUE, INC.]3Current NDC, Legacy NDC, 1 package rows20240718_8a9490c2-1fdb-43b4-aeae-6e783b333f03.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
44911-063044911-0630-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRIFOLIUM PRATENSE FLOWER4JS0838828ACTIB
KEROSENE1C89KKC04EACTIB
PHYTOLACCA AMERICANA ROOT11E6VI8VEGACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
CHELIDONIUM MAJUS WHOLE7E889U5RNNACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PHOSPHORIC ACIDE4GA8884NNACTIB
PHOSPHORUS27YLU75U4WACTIB
NITRIC ACID411VRN1TV4ACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

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
AdditivestatTRIFOLIUM PRATENSE, PETROLEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, NITRICUM ACIDUMEnergique, Inc.8a9490c2-1fdb-43b4-aeae-6e783b333f032024-07-16WarningsExact identifier
ndc (package): 44911-0630-1
ndc (product): 44911-0630
ndc11 (package): 44911063001
spl id: 91797091-444c-4929-9521-0587fa291c89
spl set id: 8a9490c2-1fdb-43b4-aeae-6e783b333f03

Reported adverse events (FAERS/openFDA)#

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