FDA.reportPublic FDA data

EpiphaniQ Oral Solution (79813-204)

Manufacturer
EpiphaniQ LLC
Effective date
2021-12-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:15:18

Label at a glance#

ProductEpiphaniQ
Active ingredientZINC IODIDE
Label structure9 sections

Indications and uses

Relieves respiratory difficulties and bronchial irritations (cough).

Dosage and administration

Oral Liquid: Shake well before use. Mix liquid as detailed below into a glass of water or juice. Adults and children 13 years and older (up to 120lbs): 5ml, three times daily For heavier body weight or very severe cases dose 10ml, three times daily Sachet: Pour contents of sachets into a glass of water or juice as detailed below Adults and children 13 years and older (up to 120lbs): 1 sachet, three times daily For...

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

ZINCUM IODATUM 2X HPUS

PURPOSE

OTC - PURPOSE SECTION

TO TREAT RESPIRATORY DIFFICULTIES, COUGH AND PERTUSSIS

USES

INDICATIONS & USAGE SECTION

Relieves respiratory difficulties and bronchial irritations (cough).

WARNINGS

WARNINGS SECTION

  • If pregnant or breast-feeding ask a healthcare professional before use
  • Children under 12: consult a doctor before use
  • Do not exceed recommended dosage
  • The use of this container by more than one person may spread infection
  • For your safety do not use if seal is broken

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

Oral Liquid:

Shake well before use.

Mix liquid as detailed below into a glass of water or juice.

  • Adults and children 13 years and older (up to 120lbs): 5ml, three times daily
  • For heavier body weight or very severe cases dose 10ml, three times daily

Sachet:

Pour contents of sachets into a glass of water or juice as detailed below

  • Adults and children 13 years and older (up to 120lbs): 1 sachet, three times daily
  • For heavier body weight or very severe cases dose 2 sachets, three times daily

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

DMSO, WATER

QUESTIONS

OTC - QUESTIONS SECTION

CALL TOLL FREE 1-800-XXX-XXXX IN THE U.S., 24 HRS, 7 DAY/WEEK

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_EpiphaniQ_Oral solution_front01b LBL_EpiphaniQ_Oral solution_front

01b LBL_EpiphaniQ_Oral solution_back01b LBL_EpiphaniQ_Oral solution_back

01b UC_EpiphaniQ_Oral Liquid_Sachet_50ct01b UC_EpiphaniQ_Oral Liquid_Sachet_50ct

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79813-204-512022-07-29C16284748780-1e4f33bdf-a3d0-d8a0-e053-dadaa90a6e4eEpiphaniQ Oral Solution (79813-204)
79813-204-522022-07-29C16284748780-1e4f33bdf-a3d0-d8a0-e053-dadaa90a6e4eEpiphaniQ Oral Solution (79813-204)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79813-204-11EpiphaniQ100 mL in 1 BOTTLESOLUTION1002
79813-204-21EpiphaniQ5 mL in 1 POUCHSOLUTION52
79813-204-51EpiphaniQ1 in 1 CARTONSOLUTION12
79813-204-52EpiphaniQ50 in 1 CARTONSOLUTION502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79813-204EPIPHANIQ (ZINCUM IODATUM) SOLUTION [EPIPHANIQ LLC]2Legacy NDC, 4 package rows20211230_229bca8f-9770-4564-bd75-39463316874f.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79813-20479813-204-11, 79813-204-51, 79813-204-21, 79813-204-52

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHYL SULFOXIDEYOW8V9698HIACT
WATER059QF0KO0RIACT
ZINC IODIDE762R7A0O0BACTIM

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
d44e89ee-1f14-48be-e053-2a95a90a360d229bca8f-9770-4564-bd75-39463316874f2021-12-29WarningsExact identifier
spl id: d44e89ee-1f14-48be-e053-2a95a90a360d
spl set id: 229bca8f-9770-4564-bd75-39463316874f

Reported adverse events (FAERS/openFDA)#

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