NDC 57687-242 Rescue Sleep

Helianthemum Nummularium Flower, Clematis Vitalba Flower, Impatiens Glandulifera Flower, Prunus Cerasifera Flower, Ornithogalum Umbellatum, And Aesculus Hippocastanum Flower

NDC Product Code 57687-242

NDC CODE: 57687-242

Proprietary Name: Rescue Sleep 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: Helianthemum Nummularium Flower, Clematis Vitalba Flower, Impatiens Glandulifera Flower, Prunus Cerasifera Flower, Ornithogalum Umbellatum, And Aesculus Hippocastanum Flower 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.

NDC Code Structure

NDC 57687-242-07

Package Description: 1 BOTTLE, SPRAY in 1 CARTON > 7 mL in 1 BOTTLE, SPRAY

NDC 57687-242-20

Package Description: 1 BOTTLE in 1 CARTON > 20 mL in 1 BOTTLE

NDC Product Information

Rescue Sleep with NDC 57687-242 is a a human over the counter drug product labeled by Nelson Bach Usa, Ltd.. The generic name of Rescue Sleep is helianthemum nummularium flower, clematis vitalba flower, impatiens glandulifera flower, prunus cerasifera flower, ornithogalum umbellatum, and aesculus hippocastanum flower. The product's dosage form is solution and is administered via oral form.

Labeler Name: Nelson Bach Usa, Ltd.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

Rescue Sleep 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.

  • HELIANTHEMUM NUMMULARIUM FLOWER 5 [hp_X]/.095mL
  • CLEMATIS VITALBA FLOWER 5 [hp_X]/.095mL
  • IMPATIENS GLANDULIFERA FLOWER 5 [hp_X]/.095mL
  • PRUNUS CERASIFERA FLOWER 5 [hp_X]/.095mL
  • ORNITHOGALUM UMBELLATUM WHOLE 5 [hp_X]/.095mL
  • AESCULUS HIPPOCASTANUM FLOWER 5 [hp_X]/.095mL

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: Nelson Bach Usa, Ltd.
Labeler Code: 57687
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: 04-21-2006 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Rescue Sleep 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

Other

Drug Facts

Distributed byNelson Bach USA Ltd.21 High Street, Suite 302N. Andover, MA 01845

Otc - Purpose

Active IngredientsEach 5X (HPUS)PurposeWhite Chestnut(Aesculus hippocastanum)Relief from repetitive thoughtsRock Rose(Helianthemum nummularium)Courage and presence of mindClematis(Clematis vitalba)Focus when ungroundedImpatiens(Impatiens glandulifera)Patience with problems and peopleCherry Plum(Prunus cerasifera)Balanced mind when losing controlStar of Bethlehem(Ornithogalum umbellatum)Softens impact of shock

Uses

  • For relief of occasional sleeplessness caused by stress and repetitive thoughts.

Otc - Ask Doctor

Ask a doctor before use in children under 12 years of age.

Otc - When Using

When using this product keep away from eyes.

Otc - Stop Use

Stop use and ask a doctor if sleeplessness persists for more than two weeks: insomnia can be a symptom of serious underlying medical illness.

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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

Directions

  • Bring spray nozzle up to mouth and apply 2 sprays onto the tongue. Additional sprays may be taken during the night as needed.

Other Information

  • Store below 77°F (25°C ).No artificial colors, artificial flavors or animal products.Active ingredients made according to the Homeopathic Pharmacopoeia of the United States (HPUS).

Inactive Ingredient

Alcohol

Questions?

Call 1-800-319-9151Mon-Fri 8am-5pm EST.

* Please review the disclaimer below.