NDC 69607-0002 Insomnia

Aquilegia Vulgaris, Avena Sativa, Chamomilla, Coffea Cruda, Cypripedium Pubescens, Humulus Lupulus, Hypericum Perforatum, Kali Phosphoricum, Melatonin, Melissa Officinalis, Natrum Muriaticum, Passiflora Incarnata, Valeriana Officinalis

NDC Product Code 69607-0002

NDC CODE: 69607-0002

Proprietary Name: Insomnia 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: Aquilegia Vulgaris, Avena Sativa, Chamomilla, Coffea Cruda, Cypripedium Pubescens, Humulus Lupulus, Hypericum Perforatum, Kali Phosphoricum, Melatonin, Melissa Officinalis, Natrum Muriaticum, Passiflora Incarnata, Valeriana Officinalis 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.

  • Melatonin has been used for short-term treatment of trouble sleeping (insomnia) due to sleep cycle disorders and time changes (jet lag). This product may help you fall asleep faster and decrease the number of times you awaken during the night. It may also help you sleep for a longer time. Melatonin is a substance that your body normally makes. It is thought to help your body's regular daily cycle, hormone production, and sleep patterns. Some herbal/diet supplement products have been found to contain possibly harmful impurities/additives. Check with your pharmacist for more details regarding the particular brand you use. The FDA has not reviewed this product for safety or effectiveness. Consult your doctor or pharmacist for more details.
  • 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.

NDC Code Structure

NDC 69607-0002-1

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Insomnia with NDC 69607-0002 is a a human over the counter drug product labeled by Biovea. The generic name of Insomnia is aquilegia vulgaris, avena sativa, chamomilla, coffea cruda, cypripedium pubescens, humulus lupulus, hypericum perforatum, kali phosphoricum, melatonin, melissa officinalis, natrum muriaticum, passiflora incarnata, valeriana officinalis. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Biovea

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.

Insomnia 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.

  • AQUILEGIA VULGARIS 2 [hp_X]/mL
  • AVENA SATIVA FLOWERING TOP 2 [hp_X]/mL
  • MATRICARIA RECUTITA 2 [hp_X]/mL
  • ARABICA COFFEE BEAN 6 [hp_X]/mL
  • CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT 3 [hp_X]/mL
  • HOPS 3 [hp_X]/mL
  • HYPERICUM PERFORATUM 6 [hp_X]/mL
  • POTASSIUM PHOSPHATE, DIBASIC 12 [hp_X]/mL
  • MELATONIN 6 [hp_X]/mL
  • MELISSA OFFICINALIS 3 [hp_X]/mL
  • SODIUM CHLORIDE 30 [hp_C]/mL
  • PASSIFLORA INCARNATA FLOWERING TOP 2 [hp_X]/mL
  • VALERIAN 2 [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.

  • WATER (UNII: 059QF0KO0R)
  • 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: Biovea
Labeler Code: 69607
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: 07-02-2015 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.

Insomnia Product Label Images

Insomnia 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:

Aquilegia Vulgaris 2X, Avena Sativa 2X, Chamomilla 2X, Coffea Cruda 6X, Cypripedium Pubescens 3X, Humulus Lupulus 3X, Hypericum Perforatum 6X, Kali Phosphoricum 12X, Melatonin 6X, Melissa Officinalis 3X, Natrum Muriaticum 30C, Passiflora Incarnata 2X, Valeriana Officinalis 2X.

Indications:

Relaxing homeopathic oral spray for the temporary relief anxiety & restlessness associated with occasional sleeplessness.††These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Relaxing homeopathic oral spray for the temporary relief anxiety & restlessness associated with occasional sleeplessness.††These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Warnings:

If symptoms persist, consult a doctor.If pregnant or breast feeding, ask a doctor before use.Keep out of reach of children. In case of accidental overdose, get medical help or call a Poison Control Center right away.Do not use if tamper evident seal is broken or missing.

Keep Out Of Reach Of Children:

Keep out of reach of children. In case of accidental overdose, get medical help or call a Poison Control Center right away.

Directions:

Adults & children over 12. Spray twice under the tongue prior to bedtime and when sleep is interrupted by restlessness. Children 12 & under. Consult a doctor prior to use.

Inactive Ingredients:

Organic alcohol 20% v/v, purified water.

Questions:

Distributed by: BIOVEADallas, TX 752021-800-961-4750www.biovea.com

Package Label Display:

NDC# 69607-0002-1BIOVEAHOMEOPATHICSInsomniaHomeopathic1 FL. OZ. (30ml)RELAXATION & SLEEP†

* Please review the disclaimer below.