NDC 17089-471 Guna Sleep Support

Avena Sativa Flowering Top - Caffeine - Matricaria Chamomilla Whole - Passiflora Incarnata Flowering Top -potassium Bromide - Zinc Valerate Dihydrate - Silver Nitrate - Strychnos Ingatii Seed -

NDC Product Code 17089-471

NDC Product Information

Guna Sleep Support with NDC 17089-471 is a a human over the counter drug product labeled by Guna Spa. The generic name of Guna Sleep Support is avena sativa flowering top - caffeine - matricaria chamomilla whole - passiflora incarnata flowering top -potassium bromide - zinc valerate dihydrate - silver nitrate - strychnos ingatii seed -. 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 Sleep Support 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.

  • POTASSIUM BROMIDE 4 [hp_X]/30mL
  • CAFFEINE 6 [hp_X]/30mL
  • AVENA SATIVA FLOWERING TOP 2 [hp_X]/30mL
  • MATRICARIA CHAMOMILLA WHOLE 2 [hp_X]/30mL
  • STRYCHNOS IGNATII SEED 4 [hp_X]/30mL
  • PASSIFLORA INCARNATA FLOWERING TOP 2 [hp_X]/30mL
  • SILVER NITRATE 30 [hp_X]/30mL
  • ZINC VALERATE DIHYDRATE 4 [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.

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: 01-17-2021 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: 12-31-2022 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 Sleep Support Product Label Images

Guna Sleep Support 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

Uses:

  • Helps to relax and fall asleep,Helps to stay asleep during the night

Indications & Usage

Take 15 minutes before meals.

Inactive Ingredient

Inactive ingredient: Ethyl alcohol 30%.

Otc - Questions

Questions?: info@gunainc.com

Tel. (484) 223-3500

Dosage & Administration

Adults and children 12 years and older: 20 drops in a little water, 2 times per day

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

Children under 6 years: consulta a physician

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding ask a health care professional before use

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 overdose, get professional assistance or contact a Poison Control Center immediately.
  • Contains ethyl alcohol 30%

Active Ingredient/Purpose

Avena sativa 2X Helps relaxation, helps sleepChamomilla 2X Helps relaxation, helps sleepCaffeinum 6X Helps relaxationIgnatia amara 4X Relieves nervousnessKali bromatum 4X Helps sleepPassiflora incarnata 2X Supports nighttime sleepZincum valerianicum 4X Supports nighttime sleep

* Please review the disclaimer below.