NDC 59623-001 Seasonal Allergy Formula

Hydrastis Canadensis, Kali Muriaticum, Gelsemium Sempervirens, Kali Bichromicum, Sabadilla, Histaminum, House Dust, Grass Mix, Trees Mix, Weeds Mix

NDC Product Code 59623-001

NDC Code: 59623-001

Proprietary Name: Seasonal Allergy Formula 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: Hydrastis Canadensis, Kali Muriaticum, Gelsemium Sempervirens, Kali Bichromicum, Sabadilla, Histaminum, House Dust, Grass Mix, Trees Mix, Weeds Mix 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

NDC 59623-001-01

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC 59623-001-02

Package Description: 59 mL in 1 BOTTLE, DROPPER

NDC Product Information

Seasonal Allergy Formula with NDC 59623-001 is a a human over the counter drug product labeled by Integrative Healing Institute, Llc. The generic name of Seasonal Allergy Formula is hydrastis canadensis, kali muriaticum, gelsemium sempervirens, kali bichromicum, sabadilla, histaminum, house dust, grass mix, trees mix, weeds mix. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Integrative Healing Institute, Llc

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.

Seasonal Allergy Formula 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.

  • GOLDENSEAL 4 [hp_X]/mL
  • POTASSIUM CHLORIDE 6 [hp_X]/mL
  • GELSEMIUM SEMPERVIRENS ROOT 12 [hp_C]/mL
  • POTASSIUM DICHROMATE 12 [hp_C]/mL
  • SCHOENOCAULON OFFICINALE SEED 12 [hp_C]/mL
  • HISTAMINE DIHYDROCHLORIDE 30 [hp_C]/mL
  • HOUSE DUST 12 [hp_X]/mL
  • ANTHOXANTHUM ODORATUM 6 [hp_X]/mL
  • BROMUS SECALINUS POLLEN 6 [hp_X]/mL
  • CYNODON DACTYLON POLLEN 6 [hp_X]/mL
  • BARLEY 6 [hp_X]/mL
  • SORGHUM HALEPENSE POLLEN 6 [hp_X]/mL
  • POA PRATENSIS POLLEN 6 [hp_X]/mL
  • MELILOTUS OFFICINALIS TOP 6 [hp_X]/mL
  • PHLEUM PRATENSE TOP 6 [hp_X]/mL
  • TRITICUM AESTIVUM POLLEN 6 [hp_X]/mL
  • ZEA MAYS POLLEN 6 [hp_X]/mL
  • AMARANTHUS RETROFLEXUS POLLEN 6 [hp_X]/mL
  • AMBROSIA ARTEMISIIFOLIA POLLEN 6 [hp_X]/mL
  • RUMEX ACETOSELLA POLLEN 6 [hp_X]/mL
  • SOLIDAGO VIRGAUREA POLLEN 6 [hp_X]/mL
  • ARTEMISIA VULGARIS POLLEN 6 [hp_X]/mL
  • ALNUS RUBRA POLLEN 6 [hp_X]/mL
  • FRAXINUS PENNSYLVANICA POLLEN 6 [hp_X]/mL
  • FRAXINUS AMERICANA POLLEN 6 [hp_X]/mL
  • BETULA PAPYRIFERA POLLEN 6 [hp_X]/mL
  • BETULA NIGRA POLLEN 6 [hp_X]/mL
  • BETULA LENTA POLLEN 6 [hp_X]/mL
  • BETULA PUBESCENS FLOWER BUD 6 [hp_X]/mL
  • ACER NEGUNDO POLLEN 6 [hp_X]/mL
  • ULMUS AMERICANA POLLEN 6 [hp_X]/mL
  • ULMUS PUMILA POLLEN 6 [hp_X]/mL
  • ULMUS RUBRA POLLEN 6 [hp_X]/mL
  • CARYA GLABRA POLLEN 6 [hp_X]/mL
  • CARYA OVATA POLLEN 6 [hp_X]/mL
  • CARYA LACINIOSA POLLEN 6 [hp_X]/mL
  • CARYA TOMENTOSA POLLEN 6 [hp_X]/mL
  • ACER RUBRUM POLLEN 6 [hp_X]/mL
  • ACER SACCHARINUM POLLEN 6 [hp_X]/mL
  • ACER SACCHARUM POLLEN 6 [hp_X]/mL
  • QUERCUS MARILANDICA POLLEN 6 [hp_X]/mL
  • QUERCUS MACROCARPA POLLEN 6 [hp_X]/mL
  • QUERCUS STELLATA POLLEN 6 [hp_X]/mL
  • QUERCUS RUBRA POLLEN 6 [hp_X]/mL
  • QUERCUS ALBA POLLEN 6 [hp_X]/mL
  • PINUS NIGRA POLLEN 6 [hp_X]/mL
  • PINUS TAEDA POLLEN 6 [hp_X]/mL
  • PINUS SYLVESTRIS POLLEN 6 [hp_X]/mL
  • PINUS STROBUS POLLEN 6 [hp_X]/mL
  • MORUS RUBRA POLLEN 6 [hp_X]/mL
  • JUNIPERUS VIRGINIANA POLLEN 6 [hp_X]/mL
  • PLATANUS OCCIDENTALIS POLLEN 6 [hp_X]/mL
  • JUGLANS REGIA POLLEN 6 [hp_X]/mL
  • POPULUS ALBA POLLEN 6 [hp_X]/mL
  • PLANTAGO LANCEOLATA POLLEN 6 [hp_X]/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.

  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • WATER (UNII: 059QF0KO0R)

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: Integrative Healing Institute, Llc
Labeler Code: 59623
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: 07-22-2013 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: 12-31-2019 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.

Seasonal Allergy Formula 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: Hydrastis Canadensis 4X HPUS, Kali Muriaticum 6X HPUS, Gelsemium Sempervirens 12C HPUS, Kali Bichromicum 12C HPUS, Sabadilla 12C HPUS, Histaminum 30C HPUS. Others: House Dust 12X, 15X, 30X, Grasses, Trees, Weeds Antigen Mix 6X, 12X, 30X.

Otc - Purpose

Purpose: Relief from sinus congestion, runny nose, itchy eyes, and sneezing.

Indications & Usage

Use: This product is a Homeopathic Dilution, formulated to support the body's immunity for the temporary relief of allergies.

Warnings

  • Warnings:Use only as directed.Stop use and consult a doctor if symptoms worsen or do not improve after 5 days.If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children.

Dosage & Administration

  • Directions: Shake bottle well before use.Adults (12 and Older) Take 6-10 drops orally (in water if desired) 1-3 times a day as needed.Children (11 and Younger) Take 4 - 6 drops orally 1-3 times a day as needed or as directed by your health care provider.Consult a Physician for use in children under 12 years of age.

Other Safety Information

  • Other information: Do not use if TAMPER EVIDENT seal around neck is broken or missing.Store at room temperature.

*For a complete list of allergens in all zones (US, Mexico and Canada), please visit our web site.*For a complete list of Mold antigens included in this product visit our website.Mfg. by: OHM Pharma, Inc., Mineral Wells, TX 76067Made in USATHE LETTERS 'HPUS' INDICATE THAT THE COMPONENTS IN THIS PRODUCT ARE OFFICIALLY MONOGRAPHED IN THE HOMOEOPATHIC PHARMACOPOEIA OF THE UNITED STATES.

Inactive Ingredient

Inactive ingredients: Citric Acid, Potassium Sorbate, Purified Water.

Otc - Questions

INTEGRATIVE HEALING INSTITUTE®San Antonio, TX 78216integrativehealingsa.comQuestions? Call1.888.841.4034

* Please review the disclaimer below.