Epiphaniq Sterile
FDA Label NDC 79813-203

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Epiphaniq Llc for the product Epiphaniq Sterile (NDC 79813-203). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

ZINCUM IODATUM 2X HPUS

Purpose

TO TREAT RESPIRATORY DIFFICULTIES, COUGH AND PERTUSSIS

Uses

Relieves respiratory difficulties and bronchial irritations (cough).

Warnings

  • 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

  • Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control center right away

Directions

Note: The EpiphaniQ inhalation solution contained in the 60 ml bottle does not require dilution. The solution should be poured directly into the nebulizer as per the instructions below.

Read complete instructions carefully before using EpiphaniQ.

  • Draw 5ml of EpiphaniQ solution into the specially marked dropper that comes with each bottle.
  • Squeeze the solution into the nebulizer reservoir through the appropriate opening
  • Gently swirl the nebulizer to mix the contents. Connect the nebulizer to the mouthpiece or facemask
  • Connect the nebulizer to the compressor
  • Sit in a comfortable upright position. Place the mouthpiece in your mouth or put on the face mask. Turn the compressor on.
  • Breathe as calmly, deeply and evenly as possible until no more mist is formed in the nebulizer chamber (about 5 – 15 minutes). At this point, the treatment is finished.
  • Clean the nebulizer (see manufacturer’s instructions)

    • Note: Can be used two – three times per day. More frequent administration or higher doses are not recommended.

Other Information

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

Inactive Ingredients

DMSO, WATER

Questions

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

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