NDC 79813-101 Epiphaniq

Zincum Iodatum

NDC Product Code 79813-101

NDC 79813-101-60

Package Description: 60 CAPSULE in 1 BOTTLE > 1 CAPSULE in 1 CAPSULE

NDC Product Information

Epiphaniq with NDC 79813-101 is a a human over the counter drug product labeled by Epiphaniq Llc. The generic name of Epiphaniq is zincum iodatum. The product's dosage form is capsule and is administered via oral form.

Labeler Name: Epiphaniq Llc

Dosage Form: Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Epiphaniq Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ZINC IODIDE 50 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ACETYLCYSTEINE (UNII: WYQ7N0BPYC)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Epiphaniq Llc
Labeler Code: 79813
Marketing Category: UNAPPROVED HOMEOPATHIC - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 07-23-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Epiphaniq Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

ZINCUM IODATUM 50 MG

Purpose

TO TREAT RESPIRATORY DIFFICULTIES, COUGH AND PERTUSSIS

Uses

Relieves respiratory difficulties and bronchial irritations (cough).

Warnings

  • Children under 12: consult a doctor before usingDo not use if the blister seal is brokenIf pregnant or breast-feeding ask a healthcare professional before useStore in a cool, dry place, away from direct light.

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

  • Adults and children up to 13 years: Take 1 capsule three times daily for weight up to 120lbs.For heavier body weight or more severe cases, take 2 capsules three times

Inactive Ingredients

NAC (N-acetyl cysteine), magnesium stearateOTHER INGREDIENTS: BOVINE GELATIN, GLYCERIN, PURIFIED WATER, TITANIUM DIOXIDE

Questions

CALL TOLL FREE 1-800-XXX-XXXX

* Please review the disclaimer below.