FDA.reportPublic FDA data

COUGHTONE

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2024-01-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:25:48

Label at a glance#

ProductCOUGHTONE
Active ingredientECHINACEA ANGUSTIFOLIA WHOLE, LOBELIA INFLATA, ANTIMONY POTASSIUM TARTRATE, ARALIA RACEMOSA ROOT, DROSERA ROTUNDIFOLIA, IPECAC, POTASSIUM CARBONATE, 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): 14.26% of Antimonium Tartaricum 12X, Aralia Racemosa 12X, Drosera (Rotundifolia) 12X, Ipecacuanha 12X, Kali Carbonicum 12X, Phosphorus 12X, Spongia Tosta 12X; 0.10% of Echinacea (Angustifolia) 3X, Lobelia Inflata 3X.

INDICATIONS:

OTC - PURPOSE SECTION

May temporarily relieve tickling, short, dry cough, barking cough, very deep cough and hoarseness.**

**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.

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.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized water, 20% Ethanol.

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.

INDICATIONS:

INDICATIONS & USAGE SECTION

May temporarily relieve tickling, short, dry cough, barking cough, very deep cough and hoarseness.**

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

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

COUGHTONE

1 fl. oz. (30 ml)

COUGHTONECOUGHTONE

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0593-12024-01-23C16284748780-1f386c649-ac23-0266-e053-dadaa90a7c1aDRUG FACTS:
44911-0593-12023-01-30C16284748780-1f386c649-ac23-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0593-1COUGHTONE30 mL in 1 BOTTLE, GLASSLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0593COUGHTONE (ECHINACEA, LOBELIA INFLATA, ANTIMONIUM TARTARICUM, ARALIA RACEMOSA, DROSERA (ROTUNDIFOLIA), IPECACUANHA, KALI CARBONICUM, PHOSPHORUS, SPONGIA TOSTA) LIQUID [ENERGIQUE, INC.]2Current NDC, Legacy NDC, 1 package rows20240124_0d4514ca-fbe0-4139-8151-aad039ccf05a.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
44911-059344911-0593-1

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
ECHINACEA ANGUSTIFOLIA WHOLEVB06AV5US8ACTIB
LOBELIA INFLATA9PP1T3TC5UACTIB
ANTIMONY POTASSIUM TARTRATEDL6OZ476V3ACTIB
ARALIA RACEMOSA ROOTT90W4582DUACTIB
DROSERA ROTUNDIFOLIAQR44N9XPJQACTIB
IPECAC62I3C8233LACTIB
POTASSIUM CARBONATEBQN1B9B9HAACTIB
PHOSPHORUS27YLU75U4WACTIB
SPONGIA OFFICINALIS SKELETON, ROASTED1PIP394IIDACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT

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
COUGHTONEECHINACEA, LOBELIA INFLATA, ANTIMONIUM TARTARICUM, ARALIA RACEMOSA, DROSERA (ROTUNDIFOLIA), IPECACUANHA, KALI CARBONICUM, PHOSPHORUS, SPONGIA TOSTAEnergique, Inc.0d4514ca-fbe0-4139-8151-aad039ccf05a2024-01-23WarningsExact identifier
ndc (package): 44911-0593-1
ndc (product): 44911-0593
ndc11 (package): 44911059301
spl id: 1da1f403-a018-4aeb-8ed3-3de8ef81ee07
spl set id: 0d4514ca-fbe0-4139-8151-aad039ccf05a

Reported adverse events (FAERS/openFDA)#

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