NDC 61096-1003 Allergease

Allium Cepa, Apis Mellifica, Aralia Rac, Arundo, Baptisia, Echinacea, Euphrasia, Gelsemium, Histaminum, Lycopodium, Rhus Tox, Sabadilla, Sanguinaria, Urtica Ur.

NDC Product Code 61096-1003

NDC Code: 61096-1003

Proprietary Name: Allergease 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: Allium Cepa, Apis Mellifica, Aralia Rac, Arundo, Baptisia, Echinacea, Euphrasia, Gelsemium, Histaminum, Lycopodium, Rhus Tox, Sabadilla, Sanguinaria, Urtica Ur. 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

  • 61096 - Eight And Company L.l.c
    • 61096-1003 - Allergease

NDC 61096-1003-1

Package Description: 1 BOTTLE, SPRAY in 1 CARTON > 41 mL in 1 BOTTLE, SPRAY

NDC Product Information

Allergease with NDC 61096-1003 is a a human over the counter drug product labeled by Eight And Company L.l.c. The generic name of Allergease is allium cepa, apis mellifica, aralia rac, arundo, baptisia, echinacea, euphrasia, gelsemium, histaminum, lycopodium, rhus tox, sabadilla, sanguinaria, urtica ur.. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Eight And Company L.l.c

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Allergease 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.

  • ONION 6 [hp_X]/41mL
  • APIS MELLIFERA 4 [hp_X]/41mL
  • ARALIA RACEMOSA ROOT 6 [hp_X]/41mL
  • ARUNDO PLINIANA ROOT 30 [hp_C]/41mL
  • BAPTISIA TINCTORIA ROOT 4 [hp_X]/41mL
  • ECHINACEA, UNSPECIFIED 4 [hp_X]/41mL
  • EUPHRASIA STRICTA 6 [hp_X]/41mL
  • GELSEMIUM SEMPERVIRENS ROOT 200 [hp_C]/41mL
  • HISTAMINE DIHYDROCHLORIDE 12 [hp_X]/41mL
  • LYCOPODIUM CLAVATUM SPORE 6 [hp_X]/41mL
  • TOXICODENDRON PUBESCENS LEAF 200 [hp_C]/41mL
  • SCHOENOCAULON OFFICINALE SEED 6 [hp_X]/41mL
  • SANGUINARIA CANADENSIS ROOT 200 [hp_C]/41mL
  • URTICA URENS 200 [hp_C]/41mL

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: Eight And Company L.l.c
Labeler Code: 61096
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: 02-26-2019 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: 12-31-2020 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.

Allergease Product Label Images

Allergease 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 Ingredients: Allium cepa 6X, Apis mellifica 3X, Aralia racemosa 6X, Arundo mauritanica 30C, Baptisia tinctoria 3X, Echinacea 4X, Euphrasia officinalis 6X, Gelsemium sempervirens 200C, Histaminum hydrochloricum 12X, Lycopodium clavatum 6X, Rhus toxicodendron 200C, Sabadilla 6X, Sanguinaria canadensis 200C, Urtica urens 3X, 200C.

Warnings

Warnings: If symptoms persist or worsen, seek advice of physician. If pregnant for breast-feeding, ask a health care professional before use. Keep out of reach of children. Contains alcohol, in case of overdose, get medical help or contact a Poison Control Center right away.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Dosage & Administration

  • Directions:Adults and children over 12: 2 sprays under the tongue each 30 minutes as needed for symptom relief the first day. 2 sprays 3 times a day thereafter.Ages 2 to 12: 1 spray under the tongue each 30 minutes as needed for symptom relief the first day, 1 spray 3 times a day thereafter.Under age 2 consult a health care professional.

Otc - Purpose

  • Temporarily relieves the symptoms of allergies and hay fever, including:runny noseitchy eyesrashheadache and sneezing

Other Safety Information

Other Information:Do not use if the transparent seal around spray bottle is broken or missing.

Inactive Ingredient

Inactive Ingredient: Glycerin 10% v/v, non-GMO organic alcohol 9% v/v, purified water.

Indications & Usage

  • AllergEase homeopathic oral spray w/EchinaceaTemporarily relieves the symptoms of allergies and hay fever, including:runny noseitchy eyesrashheadache and sneezing° natural° gluten free° no artifical flavors or colors° vegetarian° no known negative side effects° no known negative drug interactions

* Please review the disclaimer below.

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