NDC 59262-601 Sleeplessness Relief

NDC Product Code 59262-601

NDC CODE: 59262-601

Proprietary Name: Sleeplessness Relief 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.

Product Characteristics

Color(s):
WHITE (C48325)
Shape: FREEFORM (C48340)
Size(s):
1 MM
Score: 1

NDC Code Structure

  • 59262 - Similasan Corporation

NDC 59262-601-30

Package Description: 1078 GLOBULE in 1 BOTTLE, GLASS

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Sleeplessness Relief with NDC 59262-601 is a product labeled by Similasan Corporation. The product's dosage form is and is administered via form.

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.

  • CALCIUM CARBONATE (UNII: H0G9379FGK)
  • XYLITOL (UNII: VCQ006KQ1E)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Similasan Corporation
Labeler Code: 59262
Start Marketing Date: 07-02-2013 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: 12-31-2019 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: I - INACTIVATED, the listing data was inactivated by the FDA. 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.

Sleeplessness Relief Product Label Images

Sleeplessness Relief 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 Ingredient(S)

Avena sativa 12X

Hepar sulphuris 12X

Pulsatilla 15X

Zincum valerianicum 12X

Purpose

Sleeplessness, nervousness

Restlessness

Irregular/agitated sleep

Sleeplessness

Uses:

Relieves symptoms of occasional sleeplessness and/or restless sleep- Difficulty in going to sleep and frequent waking during the night- Disturbed sleep due to inability "to switch off", tenseness and restlessness- Restless, light sleep and excessive dreaming

Warnings:

- Consult a physician before use if pregnant or breast feeding.- Consult a physician if symptoms persist for more than 2 weeks or worsen.- Keep this and all medications out of the reach of children.- Do not use if tamper-evident seal is broken.- In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

Keep Out Of Reach Of Children

Keep this and all medications out of the reach of children

Directions:

For adults and children ages 2 and above:- Remove tamper-evident seal from neck of bottle.- Twist cap off bottle.- Dispense 7-10 globules, place in mouth and allow to dissolve.  Do not swallow globules.- Allow the globules to dissolve in the mouth.Occasional Sleeplessness: Take in the evening before going to bed. If you don't find relief immediately, repeat every fifteen minutes.  Also take during the night if you wake frequently.

Other Information:

Active ingredients are microdiluted in accordance with the Homeopathic Pharmacopoeia of the United States, and are therefore non-toxic and have no known side effects.

Inactive Ingredients:

Calcium carbonate, Xylitol (Sugar-free)

Questions?

Call 1-800-240-9780 for 24hr recorded product information. Representatives available, M-F, 8am-5pm (MT), or visit: www.SimilasanUSA.com

* Please review the disclaimer below.