FDA Label for Epiphaniq Sterile For Oral Inhalation Only

View Indications, Usage & Precautions

Epiphaniq Sterile For Oral Inhalation Only Product Label

The following document was submitted to the FDA by the labeler of this product Epiphaniq Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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