NDC 50845-0272 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 50845-0272

NDC CODE: 50845-0272

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

  • 50845 - Liddell Laboratories, Inc.

NDC 50845-0272-2

Package Description: 1 BOTTLE, SPRAY in 1 CARTON > 30 mL in 1 BOTTLE, SPRAY (50845-0272-1)

NDC Product Information

Insomnia with NDC 50845-0272 is a a human over the counter drug product labeled by Liddell Laboratories, Inc.. 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 spray and is administered via oral form.

Labeler Name: Liddell Laboratories, Inc.

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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 CHAMOMILLA WHOLE 2 [hp_X]/mL
  • ARABICA COFFEE BEAN 6 [hp_X]/mL
  • CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT 8 [hp_X]/mL
  • HOPS 3 [hp_X]/mL
  • HYPERICUM PERFORATUM WHOLE 6 [hp_X]/mL
  • DIBASIC POTASSIUM PHOSPHATE 12 [hp_X]/mL
  • MELATONIN 6 [hp_X]/mL
  • MELISSA OFFICINALIS WHOLE 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: Liddell Laboratories, Inc.
Labeler Code: 50845
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: 12-23-2020 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.

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:

(in each spray) 7.69% of Aquilegia Vulgaris 2X, Avena Sativa 2X, Chamomilla 2X, Coffea Cruda 6X, Cypripedium Pubescens 8X, Humulus Lupulus 3X, Hypericum Perforatum 6X, Kali Phosphoricum 12X, Melatonin 6X, Melissa Officinalis 3X, Natrum Muriaticum 30C, Passiflora Incarnata 2X, Valeriana Officinalis 2X.

Uses:

May temporarily relieve symptoms associated with occasional sleeplessness caused by:anxiety, restlessness, stress, and caffeine sensitivity****Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

May temporarily relieve symptoms associated with occasional sleeplessness caused by:anxiety, restlessness, stress, and caffeine sensitivity****Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings:

See box.Do not use if you have ever had an allergic reaction to this product or any of its ingredients.Stop use and ask a doctor if symptoms persist for more than 7 days, worsen, or if new symptoms occur.Keep out of reach of children. In case of overdose, get medical help or call a Poison Control Center right away.If pregnant or breast feeding, ask a doctor before using product.Do not use if TAMPER EVIDENT seal around neck of bottle is missing or broken.Store at room temperature.

Keep Out Of Reach Of Children.

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

Directions:

Adults and children over 12: Two sprays under the tongue prior to bedtime and when sleep is interrupted by restlessness.Children under 12: Consult a doctor prior to use.

Inactive Ingredients:

Organic alcohol 20% v/v, Purified water.

Questions:

DIST. BY:LIDDELL LABORATORIES INC.201 APPLE BLVD.WOODBINE, IA 51579WWW.LIDDELL.NET1-800-460-7733

Package Label Display:

ORAL SPRAYSLIDDELLLABORATORIESEST. 199432 InsInsomniaMay relieve symptoms associatedwith occasional sleeplessnesscaused by anxiety, restlessness,stress, or caffeine sensitivity.HOMEOPATHICDOCTOR FORMULATEDReadily absorbed. Safe.No known side effects. Easy to use.1.0 FL OZ (30 ml)

* Please review the disclaimer below.