NDC 0220-9314 Quietude

Hyoscyamus Niger, Nutmeg, Passiflora Incarnata Top, Datura Stramonium

NDC Product Code 0220-9314

NDC CODE: 0220-9314

Proprietary Name: Quietude 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: Hyoscyamus Niger, Nutmeg, Passiflora Incarnata Top, Datura Stramonium 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.

Product Characteristics

Color(s):
WHITE (C48325)
Shape: ROUND (C48348)
Size(s):
9 MM
Score: 1

NDC Code Structure

  • 0220 - Laboratoires Boiron

NDC 0220-9314-04

Package Description: 60 TABLET in 1 BOX

NDC Product Information

Quietude with NDC 0220-9314 is a a human over the counter drug product labeled by Laboratoires Boiron. The generic name of Quietude is hyoscyamus niger, nutmeg, passiflora incarnata top, datura stramonium. The product's dosage form is tablet and is administered via oral form.

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

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.

Quietude 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.


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.

  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • LACTOSE (UNII: J2B2A4N98G)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)

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: Laboratoires Boiron
Labeler Code: 0220
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: 10-01-2013 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: 12-31-2021 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.

Quietude Product Label Images

Quietude 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 - Active Ingredient

Hyoscyamus niger 3C, Nux moschata 4C, Passiflora incarnata 3X, Stramonium 6X

Indications & Usage

Temporary relieves occasional sleeplessness and/or restless sleep

Otc - Do Not Use

Do not use if glued carton end flaps are open or if the blister seal is broken

Dosage & Administration

Adults and children 12 years of age and older: Dissolve 2 tablets in the mouth 3 hours before bedtime.
Then, dissolve 2 tablets in the mouth at bedtime.



Children under 12 years of age: Ask a doctor

Inactive Ingredient

Croscarmellose sodium, lactose, magnesium stearate

How Supplied

60 tablets

Otc - Purpose

Hyoscyamus niger 3C ... Relieves restless sleep associated with nervousness



Nux moschata 4C... Relieves restless sleep



Passiflora incarnata 3X... Relieves sleeplessness associated with worries and exhaustion.



Stramonium 6X ... Relieves sleeplessness with intermittent awakening.

Storage And Handling

Store at 68-77


o F (20-25


o C)

Otc - Questions

Questions, Comments



www.boironusa.com



[email protected]




1-800-BOIRON-1



(1-800-264-7661)



Distributed by Boiron Inc.



6 campus boulevard



Newtown Square, PA



19073-3267

Otc - Ask Doctor

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

Otc - Stop Use

Stop use and ask a doctor if symptoms persists continuously for more than 2 weeks or worsen.
Insomnia may be a symptom of a serious underlying illness.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

* Please review the disclaimer below.