Flutone

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2024-03-26
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:26:29

Label at a glance#

ProductFlutone
Active ingredientBAPTISIA TINCTORIA ROOT, ECHINACEA ANGUSTIFOLIA WHOLE, PHYTOLACCA AMERICANA ROOT, GOLDENSEAL, ARSENIC TRIOXIDE, BRYONIA ALBA ROOT, EUPATORIUM PERFOLIATUM FLOWERING TOP, FERROSOFERRIC PHOSPHATE, GELSEMIUM SEMPERVIRENS ROOT, IPECAC, TOXICODENDRON PUBESCENS LEAF
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 3 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): 11.09% Arsenicum Album 12X, Bryonia (Alba) 12X, Eupatorium Perfoliatum 12X, Ferrum Phosphoricum 12X, Gelsemium Sempervirens 12X, Hydrastis Canadensis 6X, Ipecacuanha 12X, Phytolacca Decandra 4X, Rhus Tox 12X; 0.10% of Baptisia Tinctoria 3X, Echinacea (Angustifolia) 3X.

INDICATIONS:

OTC - PURPOSE SECTION

May temporarily relieve minor aches and pains in muscles and joints, fever with dryness of mucous membranes and dry cough, chilliness, and headaches.

**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

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 for more than 3 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 minor aches and pains in muscles and joints, fever with dryness of mucous membranes and dry cough, chilliness, and headaches.

**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

FLUTONE

1 fl. oz. (30 ml)

FlutoneFlutone

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
44911-0514-12024-03-26C16284748780-1ba0f9c33-5be3-a910-e053-dadaa90a0b85DRUG FACTS:
44911-0514-12023-01-30C16284748780-1ba0f9c33-5be3-a910-e053-dadaa90a0b85DRUG FACTS:
44911-0514-12021-12-22C16284748780-1ba0f9c33-5be3-a910-e053-dadaa90a0b85DRUG FACTS:
44911-0514-12021-01-29C16284748780-1ba0f9c33-5be3-a910-e053-dadaa90a0b85DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0514-1Flutone30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0514FLUTONE (BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, ARSENICUM ALBUM, BRYONIA (ALBA), EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, IPECACUANHA, RHUS TOX.) LIQUID [ENERGIQUE, INC.]3Current NDC, Legacy NDC, 1 package rows20240328_d5359dc3-e0b9-421b-9ee6-7e38e1002f00.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44911-051444911-0514-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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
FlutoneBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, ARSENICUM ALBUM, BRYONIA (ALBA), EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, IPECACUANHA, RHUS TOX.Energique, Inc.d5359dc3-e0b9-421b-9ee6-7e38e1002f002024-03-26WarningsExact identifier
ndc (package): 44911-0514-1
ndc (product): 44911-0514
ndc11 (package): 44911051401
spl id: cf71dcb5-9fbc-4a0f-abbf-a76fd866754b
spl set id: d5359dc3-e0b9-421b-9ee6-7e38e1002f00

Reported adverse events (FAERS/openFDA)#

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