NDC 17089-461 Guna Allergy

Adrenalinum - Allium Cepa - Ammonium Carbonicum - Apis Mellifica - Argentum Nitricum - Arsenicum Album - Cuprum Aceticum - Galphimia Glauca - Glandula Suprarenalis Suis - Histaminum Hydrochloricum - Luffa Operculata - Matricaria Chamomilla - Mucosa Nasalis Suis - Natrum Muriaticum - Sabadilla - Scilla Maritima -

NDC Product Code 17089-461

NDC CODE: 17089-461

Proprietary Name: Guna Allergy 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: Adrenalinum - Allium Cepa - Ammonium Carbonicum - Apis Mellifica - Argentum Nitricum - Arsenicum Album - Cuprum Aceticum - Galphimia Glauca - Glandula Suprarenalis Suis - Histaminum Hydrochloricum - Luffa Operculata - Matricaria Chamomilla - Mucosa Nasalis Suis - Natrum Muriaticum - Sabadilla - Scilla Maritima - 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.

  • Drug uses not available
  • Drug uses not available
  • 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.
  • Arsenic trioxide is used to treat a type of leukemia (acute promyelocytic leukemia-APL).

NDC Code Structure

NDC 17089-461-18

Package Description: 1 BOTTLE, DROPPER in 1 BOX > 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Guna Allergy with NDC 17089-461 is a a human over the counter drug product labeled by Guna Spa. The generic name of Guna Allergy is adrenalinum - allium cepa - ammonium carbonicum - apis mellifica - argentum nitricum - arsenicum album - cuprum aceticum - galphimia glauca - glandula suprarenalis suis - histaminum hydrochloricum - luffa operculata - matricaria chamomilla - mucosa nasalis suis - natrum muriaticum - sabadilla - scilla maritima -. The product's dosage form is solution/ drops and is administered via oral form.

Labeler Name: Guna Spa

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.

Guna Allergy 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.

  • HISTAMINE DIHYDROCHLORIDE 200 [hp_X]/30mL
  • SUS SCROFA ADRENAL GLAND 6 [hp_X]/30mL
  • EPINEPHRINE 6 [hp_X]/30mL
  • APIS MELLIFERA 200 [hp_X]/30mL
  • CUPRIC ACETATE 12 [hp_X]/30mL
  • SILVER NITRATE 30 [hp_X]/30mL
  • DRIMIA MARITIMA BULB 12 [hp_X]/30mL
  • GALPHIMIA GLAUCA FLOWERING TOP 6 [hp_X]/30mL
  • SCHOENOCAULON OFFICINALE SEED 12 [hp_X]/30mL
  • SODIUM CHLORIDE 12 [hp_X]/30mL
  • LUFFA OPERCULATA FRUIT 6 [hp_X]/30mL
  • MATRICARIA CHAMOMILLA WHOLE 3 [hp_X]/30mL
  • AMMONIUM CARBONATE 12 [hp_X]/30mL
  • ONION 12 [hp_X]/30mL
  • ARSENIC TRIOXIDE 12 [hp_X]/30mL
  • SUS SCROFA NASAL MUCOSA 200 [hp_X]/30mL

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)

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.
  • 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: Guna Spa
Labeler Code: 17089
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: 09-24-2020 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.

Guna Allergy Product Label Images

Guna Allergy 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 Ingredients/Purpose

MATRICARIA CHAMOMILLA 3X RELIEVES INFLAMMATIONGLANDULA SUPRARENALIS SUIS 6X 12X 30X SUPPORTS METABOLISM
MUCOSA NASALIS SUIS 200X RELIEVES ALLERGY SYMPTOMSSCILLA MARITIMA 12X 30X 200X SUPPORTS METABOLISMSABADILLA 12X 30X 200X RELIEVES HAY FEVERALLIUM CEPA 12X 30X 200X RELIEVES RESPIRATORY CONGESTIONAMMONIUM CARBONICUM 12X 30X 200X RELIEVES RESPIRATORY CONGESTION

APIS MELLIFICA 200X HELPS REDUCE SWELLING

ARSENICUM ALBUM 12X 30X 200X RELIEVES INFLAMMATION

CUPRUM ACETICUM 12X 30X 200X RELIEVES HAY FEVER, PERSISTENT COUGH

GALPHIMIA GLAUCA 6X 12X 200X RELIEVES HAY FEVER

LUFFA OPERCULATA 6X 12X 30X RELIEVES HAY FEVER
HISTAMINUM HYDROCHLORICUM 200X RELIEVES ALLERGY SYMPTOMS

NATRUM MURIATICUM 12X 30X 200X RELIEVES ALLERGY SYMPTOMS
ARGENTUM NITRICUM 30X RELIEVES INFLAMMATIONADRENALINUM 6X IMMUNE SUPPORT

Warnings

  • Stop use and ask doctor if symptoms persist more than 5 days.
  • If pregnant or breast-feeding ask a health care professional before use.
  • Keep out of reach of children.In case of accidental overdose, seek professional assistance or contact a poison control center immediately.Contains ethyl alcohol 30%

Keep out of the reach of children

Directions

Take 15 minutes before meals.Adults and children 12 years and older: 20 drops in a little water 2 times per day

Children between 12 years and 6 years of age :10 drops in a little water 2 times per day

Children under 6 years: consult a physician

Questions

Questions?: info@gunainc.com, tel. (484) 223-3500

Indications & Usage

Take 15 minutes before meals.

Inactive Ingredient

Inactive ingredient: Ethyl alcohol 30%.

Purpose

  • TEMPORARILY RELIEVES SYMPTOMS OF SEASONAL ALLERGIES SUCH AS:SNEEZINGNASAL DISCHARGEITCHY, WATERY EYES

Otc - Do Not Use

DO NOT USEIf tamper-evident seal is brokenstop use and ask doctor if symptoms persist more than 5 days

* Please review the disclaimer below.