NDC 17089-453 Guna-cough

Althaea Officinalis Leaf - Antimony Potassium Tartrate - Bryonia Alba Root - Cetraria Islandica Subsp. Islandica - Cochineal - Copper - Drosera Rotundifolia - Echinacea Angustifolia - Garden Thyme - Lobaria Pulmonaria - Plantago Major -

NDC Product Code 17089-453

NDC Product Information

Guna-cough with NDC 17089-453 is a a human over the counter drug product labeled by Guna Spa. The generic name of Guna-cough is althaea officinalis leaf - antimony potassium tartrate - bryonia alba root - cetraria islandica subsp. islandica - cochineal - copper - drosera rotundifolia - echinacea angustifolia - garden thyme - lobaria pulmonaria - plantago major -. 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-cough 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.

  • ALTHAEA OFFICINALIS LEAF 1 [hp_X]/150mL
  • ANTIMONY POTASSIUM TARTRATE 8 [hp_X]/150mL
  • BRYONIA ALBA ROOT 6 [hp_X]/150mL
  • CETRARIA ISLANDICA SUBSP. ISLANDICA 4 [hp_X]/150mL
  • COCHINEAL 6 [hp_X]/150mL
  • COPPER 8 [hp_X]/150mL
  • DROSERA ROTUNDIFOLIA 1 [hp_X]/150mL
  • ECHINACEA ANGUSTIFOLIA 1 [hp_X]/150mL
  • PLANTAGO MAJOR 1 [hp_X]/150mL
  • LOBARIA PULMONARIA 4 [hp_X]/150mL
  • THYME 1 [hp_X]/150mL

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.

  • FRUCTOSE (UNII: 6YSS42VSEV)
  • HYPROMELLOSE (UNII: 3NXW29V3WO)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)

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: 05-27-2010 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-cough Product Label Images

Guna-cough 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

ALTHAEA OFFICINALIS    1X    EXPECTORANTANTIMONIUM TARTARICUM    8X    ANTITUSSIVE, DRY COUGHBRYONIA ALBA                6X    ANTI-INFLAMMATORYCETRARIA ISLANDICA      4X    EXPECTORANT COCCUS CACTI                6X    ANTITUSSIVE, WET COUGHCUPRUM ACETICUM        8X    PAIN RELIEFDROSERA                       1X    COUGH SUPPRESSANT, SPASMODIC COUGHECHINACEA ANGUSTIFOLIA    1X    IMMUNE SUPPORTPLANTAGO MAJOR        1X    EXPECTORANTSTICTA PULMONARIA    4X    ANTITUSSIVETHYME                          1X    EXPECTORANT

Uses

For the temporary relief of coughs due to minor throat and bronchial irritation from inhaled irritants. Helps loosen phlegm (mucous) and thin bronchial secretions to make coughs more productive

Warnings

Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or a cough accompanied by too much phlegm (mucus). Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

Keep this and all medicines out of reach of children

Pregnancy

If pregnant or breast-feeding ask a doctor before use

Directions

Use enclosed dosage cup for dosingAdults and children 12 years and older    10 ml  every 4 hours as neededChildren between 12 years and 2 years of age    5 ml  every 4 hours as neededChildren under 2 years     Ask a physician

Questions

Questions?: info@gunainc.comTel. (484) 223-3500

* Please review the disclaimer below.