EpiphaniQ Nebulizer Solution (79813-203)

Manufacturer
EpiphaniQ LLC
Effective date
2021-12-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:15:24

Label at a glance#

ProductEpiphaniQ Sterile For Oral INhalation Only
Active ingredientZINC IODIDE
Label structure10 sections

Indications and uses

Relieves respiratory difficulties and bronchial irritations (cough).

Dosage and administration

Note: The dosage as outlined below should be poured directly into the nebulizer in accordance with your nebulizer manufacturer's instructions. Read complete instructions carefully before using EpiphaniQ. 1. Connect the nebulizer to the mouthpiece or face mask 2. Connect the nebulizer to the compressor 3. Pour 5ml of undiluted EpiphaniQ solution into the nebulizer as per the manufacturer's instructions. 4. Sit in a...

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

When using this product

  • 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

Note: The dosage as outlined below should be poured directly into the nebulizer in accordance with your nebulizer manufacturer's instructions.

Read complete instructions carefully before using EpiphaniQ.


1. Connect the nebulizer to the mouthpiece or face mask
2. Connect the nebulizer to the compressor
3. Pour 5ml of undiluted EpiphaniQ solution into the nebulizer as per the manufacturer's instructions.
4. Sit in a comfortable upright position. Place the mouthpiece in your mouth or put on the face mask. Turn the compressor on.
5. Breathe as calmly, deeply and evenly as possible until no more mist is formed in the nebulizer chamber (about 15-30 minutes). At this point,
the treatment is finished.
6. Clean the nebulizer (refer to manufacturer’s instructions)

Other Information

OTHER SAFETY INFORMATION

Store at room temperature away from direct light. Does not require refrigeration.

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 UC_EpiphaniQ_Nebulizer01b UC_EpiphaniQ_Nebulizer

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79813-203-512022-07-29C16284748780-1e4f33bdf-ac47-d8a0-e053-dadaa90a6e4eEpiphaniQ Nebulizer Solution (79813-203)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79813-203-11EpiphaniQ SterileFor Oral INhalation Only60 mL in 1 BOTTLEINHALANT603
79813-203-51EpiphaniQ SterileFor Oral INhalation Only1 in 1 CARTONINHALANT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79813-203EPIPHANIQ STERILE FOR ORAL INHALATION ONLY (ZINCUM IODATUM) INHALANT [EPIPHANIQ LLC]3Legacy NDC, 2 package rows20211230_8bbf8d49-3274-4d59-a14e-d23e1eff073b.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
79813-20379813-203-11, 79813-203-51

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
d44e7e51-f886-dd17-e053-2a95a90aed458bbf8d49-3274-4d59-a14e-d23e1eff073b2021-12-29WarningsExact identifier
spl id: d44e7e51-f886-dd17-e053-2a95a90aed45
spl set id: 8bbf8d49-3274-4d59-a14e-d23e1eff073b

Reported adverse events (FAERS/openFDA)#

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