NDC 55714-2562 Hay Fever

Apis Mellifica, Echinacea, Hydrastis Canadensis, Taraxacum Officinale, Aconitum Napellus, Alfalfa, Allium Cepa, Ambrosia Artemisiaefolia, Ammonium Carbonicum, Aralia Racemosa, Arsenicum Album, Artemisia Vulgaris, Arundo Mauritanica, Bellis Perennis, Berberis Vulgaris, Bryonia, Calluna Vulgaris, Flos, Chelidonium Majus, Chenopodium Anthelminticum, Cistus Canadensis, Drosera, Dulcamara, Eupatorium Perfoliatum, Euphrasia Officinalis, Fagus Sylvatica, Fraxinus Americana, Gelsemium Sempervirens

NDC Product Code 55714-2562

NDC CODE: 55714-2562

Proprietary Name: Hay Fever 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: Apis Mellifica, Echinacea, Hydrastis Canadensis, Taraxacum Officinale, Aconitum Napellus, Alfalfa, Allium Cepa, Ambrosia Artemisiaefolia, Ammonium Carbonicum, Aralia Racemosa, Arsenicum Album, Artemisia Vulgaris, Arundo Mauritanica, Bellis Perennis, Berberis Vulgaris, Bryonia, Calluna Vulgaris, Flos, Chelidonium Majus, Chenopodium Anthelminticum, Cistus Canadensis, Drosera, Dulcamara, Eupatorium Perfoliatum, Euphrasia Officinalis, Fagus Sylvatica, Fraxinus Americana, Gelsemium Sempervirens 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This product is used to treat dryness inside the nose (nasal passages). It helps add moisture inside the nose to dissolve and soften thick or crusty mucus. In babies and young children with stuffy noses who cannot blow their noses, using this product helps to make the mucus easier to remove with a nasal bulb syringe. This helps relieve stuffiness and makes breathing easier. This product contains a purified gentle salt solution (also called saline or sodium chloride solution). It does not contain any medication.
  • Potassium iodide is used to loosen and break up mucus in the airways. This helps you cough up the mucus so you can breathe more easily if you have long-term lung problems (e.g., asthma, chronic bronchitis, emphysema). This medication is known as an expectorant. Potassium iodide is also used along with antithyroid medicines to prepare the thyroid gland for surgical removal, to treat certain overactive thyroid conditions (hyperthyroidism), and to protect the thyroid in a radiation exposure emergency. It works by shrinking the size of the thyroid gland and decreasing the amount of thyroid hormones produced. In a radiation emergency, potassium iodide blocks only the thyroid from absorbing radioactive iodine, protecting it from damage and reducing the risk of thyroid cancer. Use this medication along with other emergency measures that will be recommended to you by public health and safety officials (e.g., finding safe shelter, evacuation, controlling food supply).
  • Arsenic trioxide is used to treat a type of leukemia (acute promyelocytic leukemia-APL).

NDC Code Structure

  • 55714 - Newton Laboratories, Inc.

NDC 55714-2562-1

Package Description: 30 mL in 1 BOTTLE, GLASS

NDC Product Information

Hay Fever with NDC 55714-2562 is a a human over the counter drug product labeled by Newton Laboratories, Inc.. The generic name of Hay Fever is apis mellifica, echinacea, hydrastis canadensis, taraxacum officinale, aconitum napellus, alfalfa, allium cepa, ambrosia artemisiaefolia, ammonium carbonicum, aralia racemosa, arsenicum album, artemisia vulgaris, arundo mauritanica, bellis perennis, berberis vulgaris, bryonia, calluna vulgaris, flos, chelidonium majus, chenopodium anthelminticum, cistus canadensis, drosera, dulcamara, eupatorium perfoliatum, euphrasia officinalis, fagus sylvatica, fraxinus americana, gelsemium sempervirens. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Newton Laboratories, Inc.

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.

Hay Fever 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.

  • LILIUM LANCIFOLIUM WHOLE FLOWERING 15 [hp_X]/mL
  • SODIUM CHLORIDE 15 [hp_X]/mL
  • POPULUS BALSAMIFERA LEAF BUD 15 [hp_X]/mL
  • ANEMONE PULSATILLA 15 [hp_X]/mL
  • EUPATORIUM PERFOLIATUM FLOWERING TOP 15 [hp_X]/mL
  • EUPHRASIA STRICTA 15 [hp_X]/mL
  • GELSEMIUM SEMPERVIRENS ROOT 15 [hp_X]/mL
  • ONOSMODIUM VIRGINIANUM 15 [hp_X]/mL
  • SCHOENOCAULON OFFICINALE SEED 15 [hp_X]/mL
  • SANGUINARIA CANADENSIS ROOT 15 [hp_X]/mL
  • SOLIDAGO VIRGAUREA FLOWERING TOP 15 [hp_X]/mL
  • TRILLIUM ERECTUM ROOT 15 [hp_X]/mL
  • ULMUS RUBRA BARK 16 [hp_X]/mL
  • HISTAMINE DIHYDROCHLORIDE 15 [hp_X]/mL
  • XEROPHYLLUM ASPHODELOIDES 15 [hp_X]/mL
  • USTILAGO MAYDIS 15 [hp_X]/mL
  • PARTHENIUM HYSTEROPHORUS 16 [hp_X]/mL
  • POTASSIUM IODIDE 15 [hp_X]/mL
  • LYCOPODIUM CLAVATUM SPORE 15 [hp_X]/mL
  • POPULUS TREMULOIDES LEAF 15 [hp_X]/mL
  • ROSA X DAMASCENA FLOWERING TOP 15 [hp_X]/mL
  • SALIX NIGRA BARK 15 [hp_X]/mL
  • ELYMUS REPENS ROOT 15 [hp_X]/mL
  • DATURA STRAMONIUM 15 [hp_X]/mL
  • URTICA URENS 15 [hp_X]/mL
  • WYETHIA HELENIOIDES ROOT 15 [hp_X]/mL
  • QUERCUS ROBUR NUT 15 [hp_X]/mL
  • APIS MELLIFERA 6 [hp_X]/mL
  • GOLDENSEAL 6 [hp_X]/mL
  • TARAXACUM OFFICINALE 6 [hp_X]/mL
  • ACONITUM NAPELLUS 15 [hp_X]/mL
  • ALFALFA 15 [hp_X]/mL
  • ONION 15 [hp_X]/mL
  • AMBROSIA ARTEMISIIFOLIA 15 [hp_X]/mL
  • AMMONIUM CARBONATE 15 [hp_X]/mL
  • ARALIA RACEMOSA ROOT 15 [hp_X]/mL
  • ARSENIC TRIOXIDE 15 [hp_X]/mL
  • ARTEMISIA VULGARIS ROOT 15 [hp_X]/mL
  • ARUNDO PLINIANA ROOT 15 [hp_X]/mL
  • BELLIS PERENNIS 15 [hp_X]/mL
  • BERBERIS VULGARIS ROOT BARK 15 [hp_X]/mL
  • BRYONIA ALBA ROOT 15 [hp_X]/mL
  • CALLUNA VULGARIS FLOWERING TOP 15 [hp_X]/mL
  • CHELIDONIUM MAJUS 15 [hp_X]/mL
  • DYSPHANIA AMBROSIOIDES 15 [hp_X]/mL
  • HELIANTHEMUM CANADENSE 15 [hp_X]/mL
  • DROSERA ANGLICA 15 [hp_X]/mL
  • SOLANUM DULCAMARA TOP 15 [hp_X]/mL
  • ECHINACEA, UNSPECIFIED 6 [hp_X]/mL
  • FAGUS SYLVATICA NUT 15 [hp_X]/mL
  • FRAXINUS AMERICANA BARK 15 [hp_X]/mL
  • CALCIUM SULFIDE 15 [hp_X]/mL
  • POTASSIUM DICHROMATE 15 [hp_X]/mL
  • LACHESIS MUTA VENOM 15 [hp_X]/mL
  • RHODODENDRON TOMENTOSUM LEAFY TWIG 15 [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.

  • ALCOHOL (UNII: 3K9958V90M)
  • 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: Newton Laboratories, Inc.
Labeler Code: 55714
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: 05-18-2020 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.

Hay Fever Product Label Images

Hay Fever 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

Indications & Usage Section

Formulated for associated symptoms of late Summer and Fall pollens such as itchy eyes, sneezing, post-nasal drip, sore throat and sinus pressure.

Dosage & Administration Section

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

Otc - Active Ingredient Section

Equal parts of Apis mellifica 6x, Echinacea 6x, Hydrastis canadensis 6x, Taraxacum officinale 6x, Aconitum napellus 15x, Alfalfa 15x, Allium cepa 15x, Ambrosia artemisiaefolia 15x, Ammonium carbonicum 15x, Aralia racemosa 15x, Arsenicum album 15x, Artemisia vulgaris 15x, Arundo mauritanica 15x, Bellis perennis 15x, Berberis vulgaris 15x, Bryonia 15x, Calluna vulgaris, flos 15x, Chelidonium majus 15x, Chenopodium anthelminticum 15x, Cistus canadensis 15x, Drosera 15x, Dulcamara 15x, Eupatorium perfoliatum 15x, Euphrasia officinalis 15x, Fagus sylvatica 15x, Fraxinus americana 15x, Gelsemium sempervirens 15x, Hepar sulphuris calcareum 15x, Histaminum hydrochloricum 15x, Kali bichromicum 15x, Kali iodatum 15x, Lachesis mutus 15x, Ledum palustre 15x, Lillium tigrinum 15x, Lycopodium clavatum 15x, Natrum muriaticum 15x, Onosmodium virginianum 15x, Populus candicans 15x, Populus tremuloides 15x, Pulsatilla 15x, Quercus glandium spiritus 15x, Rosa damascena 15x, Sabadilla 15x, Salix nigra 15x, Sanguinaria canadensis 15x, Solidago virgaurea 15x, Stramonium 15x, Trillium pendulum 15x, Triticum repens 15x, Urtica urens 15x, Ustilago maidis 15x, Wyethia helenoides 15x, Xerophyllum asphodeloides 15x, Parthenium 16x, Ulmus fulva 16x.

Inactive Ingredient Section

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

Questions Section

Newtonlabs.net – Questions? 800.448.7256Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

Warnings Section

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If
pregnant or breast-feeding, ask a doctor before use.

Otc - Pregnancy Or Breast Feeding Section

If
pregnant or breast-feeding, ask a doctor before use.

Otc - Keep Out Of Reach Of Children Section

Keep out of reach of children.

* Please review the disclaimer below.