NDC 63479-0603 F03 Fr-rls

Aspen, Arsenicum Album, Diplacus Aurantiacus, Garlic, Lilium Tigrinum, Loquat, Luffa Operculata, Mimulus Guttatus, Penstemon Davidsonii, Prunus Cerasifera, Red Horse Chestnut, Rubus Ursinus, Rockrose, Toxicodendron Diversilobum, Viola Odorata, Watermelon, Yellow Jasmine

NDC Product Code 63479-0603

NDC CODE: 63479-0603

Proprietary Name: F03 Fr-rls What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Aspen, Arsenicum Album, Diplacus Aurantiacus, Garlic, Lilium Tigrinum, Loquat, Luffa Operculata, Mimulus Guttatus, Penstemon Davidsonii, Prunus Cerasifera, Red Horse Chestnut, Rubus Ursinus, Rockrose, Toxicodendron Diversilobum, Viola Odorata, Watermelon, Yellow Jasmine What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 63479 - Apex Energetics Inc.

NDC 63479-0603-1

Package Description: 30 mL in 1 BOTTLE, GLASS

NDC Product Information

F03 Fr-rls with NDC 63479-0603 is a a human over the counter drug product labeled by Apex Energetics Inc.. The generic name of F03 Fr-rls is aspen, arsenicum album, diplacus aurantiacus, garlic, lilium tigrinum, loquat, luffa operculata, mimulus guttatus, penstemon davidsonii, prunus cerasifera, red horse chestnut, rubus ursinus, rockrose, toxicodendron diversilobum, viola odorata, watermelon, yellow jasmine. The product's dosage form is solution/ drops and is administered via sublingual form.

Labeler Name: Apex Energetics Inc.

Dosage Form: Solution/ Drops - A solution which is usually administered in a drop-wise fashion.

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.

F03 Fr-rls 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.

  • ARSENIC TRIOXIDE 20 [hp_C]/mL
  • VIOLA ODORATA FLOWER 12 [hp_C]/mL
  • GELSEMIUM SEMPERVIRENS ROOT 20 [hp_C]/mL
  • ERIOBOTRYA JAPONICA WHOLE 12 [hp_C]/mL
  • LUFFA OPERCULATA FRUIT 12 [hp_C]/mL
  • MIMULUS GUTTATUS FLOWERING TOP 12 [hp_C]/mL
  • TOXICODENDRON DIVERSILOBUM WHOLE 12 [hp_C]/mL
  • PENSTEMON DAVIDSONII WHOLE 12 [hp_C]/mL
  • AESCULUS CARNEA FLOWER 12 [hp_C]/mL
  • RUBUS URSINUS WHOLE 12 [hp_C]/mL
  • PRUNUS CERASIFERA FLOWER 12 [hp_C]/mL
  • ALLIUM SATIVUM WHOLE 12 [hp_C]/mL
  • POPULUS TREMULA FLOWERING TOP 12 [hp_C]/mL
  • DIPLACUS AURANTIACUS WHOLE 12 [hp_C]/mL
  • HELIANTHEMUM NUMMULARIUM FLOWER 12 [hp_C]/mL
  • WATERMELON 12 [hp_C]/mL
  • LILIUM LANCIFOLIUM WHOLE FLOWERING 20 [hp_C]/mL

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.

  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)

Administration Route(s)

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

  • Sublingual - Administration beneath the tongue.

Product Labeler Information

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

Labeler Name: Apex Energetics Inc.
Labeler Code: 63479
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: 03-12-1996 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

F03 Fr-rls Product Label Images

F03 Fr-rls 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

Otc - Active Ingredient

Active IngredientsArsenicum Album6C 9C 12C 15C 20CCalifornia Blackberry Whole6C 9C 12CCherry Plum Flower6C 9C 12CCommon Violet Flower6C 9C 12CCultivated Garlic Whole6C 9C 12CEuropean Aspen Flowering Top6C 9C 12CGelsemium Sempervirens6C 9C 12C 15C 20CLilium Tigrinum6C 9C 12C 15C 20CLoquat Whole6C 9C 12CLuffa Operculata6C 9C 12CMimulus Guttatus Flowering Top6C 9C 12COrange Bush Monkeyflower Whole6C 9C 12CPacific Poisonoak Whole6C 9C 12CPenstemon Davidsonii Whole6C 9C 12CRed Horse-Chestnut Flower6C 9C 12CRockrose Flower6C 9C 12CWatermelon6C 9C 12C

Otc - Purpose

For temporary relief of minor:restlessness*fearfulness*backache*cold sweat*buzzing ears*weak memory*dizziness**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, ask a health professional before use.

Other Safety Information

Do not use if clear seal over the cap is broken or missing.

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.

Otc - Stop Use

Stop use and ask a doctor if restlessness, fearfulness, backache, cold sweat, buzzing ears, weak memory, dizziness, or other symptoms do not improve within 7 days or are accompanied by fever.

Directions:

Adults & children ages 12 years and over: Take 10 drops under the tongue 3 times a day, or as directed by your healthcare professional. Consult a physician for use in children under 12 years of age.

Inactive Ingredient

Alcohol (20% by volume), distilled water

Otc - Questions

Distributed by Apex Energetics. Questions?16592 Hale Ave., Irvine, CA 92606, USA

* Please review the disclaimer below.