Breathtone

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2023-08-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:22:01

Label at a glance#

ProductBreathtone
Active ingredientLOBELIA INFLATA WHOLE, VERBASCUM THAPSUS WHOLE, BALSAM PERU, ANTIMONY POTASSIUM TARTRATE, ARSENIC TRIOXIDE, DROSERA ROTUNDIFOLIA WHOLE, POTASSIUM DICHROMATE, POTASSIUM CARBONATE, SODIUM SULFATE, PHOSPHORUS, SPONGIA OFFICINALIS SKELETON, ROASTED
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): 12.46% of Antimonium Tartaricum 12X, Arsenicum Album 12X, Drosera (Rotundifolia) 12X, Kali Bichromicum 12X, Kali Carbonicum 12X, Natrum Sulphuricum 12X, Phosphorous 12X, Spongia Tosta 12X; 0.10% of Balsamum Peruvianum 6X, Lobelia Inflata 3X, Verbascum Thapsus 3X.

INDICATIONS:

OTC - PURPOSE SECTION

May temporarily relieve dry hacking cough, hoarseness, bronchial congestion and hay fever symptoms, and difficulty breathing with tightness of chest from congestion of chest.**

**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 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 dry hacking cough, hoarseness, bronchial congestion and hay fever symptoms, and difficulty breathing with tightness of chest from congestion of chest.**

**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

BREATHTONE

1 fl. oz. (30 ml)

BREATHTONEBREATHTONE

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0590-12023-08-14C16284748780-1f386c649-b0b8-0266-e053-dadaa90a7c1aDRUG FACTS:
44911-0590-12023-01-30C16284748780-1f386c649-b0b8-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0590-1Breathtone30 mL in 1 BOTTLE, DROPPERLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0590BREATHTONE (LOBELIA INFLATA, VERBASCUM THAPSUS, BALSAMUM PERUVIANUM, ANTIMONIUM TARTARICUM, ARSENICUM ALBUM, DROSERA (ROTUNDIFOLIA), KALI BICHROMICUM, KALI CARBONICUM, NATRUM SULPHURICUM, PHOSPHOROUS, SPONGIA TOSTA) LIQUID [ENERGIQUE, INC.]2Current NDC, Legacy NDC, 1 package rows20230815_c388da29-824a-41a5-be85-47a60bccf3da.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44911-059044911-0590-1

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
BreathtoneLOBELIA INFLATA, VERBASCUM THAPSUS, BALSAMUM PERUVIANUM, ANTIMONIUM TARTARICUM, ARSENICUM ALBUM, DROSERA (ROTUNDIFOLIA), KALI BICHROMICUM, KALI CARBONICUM, NATRUM SULPHURICUM, PHOSPHOROUS, SPONGIA TOSTAEnergique, Inc.c388da29-824a-41a5-be85-47a60bccf3da2023-08-14WarningsExact identifier
ndc (package): 44911-0590-1
ndc (product): 44911-0590
ndc11 (package): 44911059001
spl id: f5157189-1447-4dd3-b342-0c14ccaffcef
spl set id: c388da29-824a-41a5-be85-47a60bccf3da

Reported adverse events (FAERS/openFDA)#

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