NDC 57687-303 Rescue Pastille Lemon

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

NDC Product Code 57687-303

NDC CODE: 57687-303

Proprietary Name: Rescue Pastille Lemon 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 Top, Impatiens Glandulifera Flower, Prunus Cerasifera Flower, And Ornithogalum Umbellatum 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 57687-303-02

Package Description: 2 LOZENGE in 1 POUCH

NDC 57687-303-50

Package Description: 35 LOZENGE in 1 CONTAINER

NDC Product Information

Rescue Pastille Lemon with NDC 57687-303 is a a human over the counter drug product labeled by Nelson Bach Usa Ltd. The generic name of Rescue Pastille Lemon is helianthemum nummularium flower, clematis vitalba top, impatiens glandulifera flower, prunus cerasifera flower, and ornithogalum umbellatum. The product's dosage form is lozenge and is administered via oral form.

Labeler Name: Nelson Bach Usa Ltd

Dosage Form: Lozenge - A solid preparation containing one or more medicaments, usually in a flavored, sweetened base which is intended to dissolve or disintegrate slowly in the mouth. A lollipop is a lozenge on a stick.

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 Pastille Lemon 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]/1
  • CLEMATIS VITALBA TOP 5 [hp_X]/1
  • IMPATIENS GLANDULIFERA FLOWER 5 [hp_X]/1
  • PRUNUS CERASIFERA FLOWER 5 [hp_X]/1
  • ORNITHOGALUM UMBELLATUM 5 [hp_X]/1

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.

  • SORBITOL (UNII: 506T60A25R)
  • MALTITOL (UNII: D65DG142WK)
  • ISOMALT (UNII: S870P55O2W)
  • ACACIA (UNII: 5C5403N26O)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • XYLITOL (UNII: VCQ006KQ1E)
  • YELLOW WAX (UNII: 2ZA36H0S2V)

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: 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: 01-30-2014 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: 12-31-2020 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.

Rescue Pastille Lemon 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

Otc - Purpose

For relief of occasional stress.

Directions

Chew one pastille as required. Each pastille contains the equivalent of 1 dose of RESCUE® Remedy.

Active Ingredients

5x dilution of Helianthemum nummularium HPUS, Clematis vitalba HPUS, Impatiens glandulifera HPUS, Prunus cerasifera HPUS, Ornithogalum umbellatum HPUS.

Inactive Ingredients

Sugar substitutes (sorbitol, maltitol, isomalt), gelling agent (gum arabic), citric acid, natural flavor (lemon), natural color (turmeric), sweetener (xylitol), glazing agent (vegetable oil, beeswax).

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Otc - Pregnancy Or Breast Feeding

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

Other

Excessive consumption may induce mild laxative effects.May contain traces of gluten.

Distributed by Nelsons, North Andover, MA 01845

Storage And Handling

Store below 77°F (25°C).

Otc - Do Not Use

Do not use if seal is broken.Not suitable for animals.

Questions?

1-800-319-9151

* Please review the disclaimer below.