NDC 0220-9332 Sedalia

Aconitum Napellus, Belladonna Leaf, Calendula Officinalis Flowering Top, Chelidonium Majus, Abrus Precatorius Seed, Viburnum Opulus Root

NDC Product Code 0220-9332

NDC Code: 0220-9332

Proprietary Name: Sedalia 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: Aconitum Napellus, Belladonna Leaf, Calendula Officinalis Flowering Top, Chelidonium Majus, Abrus Precatorius Seed, Viburnum Opulus Root 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
Imprint(s):
;
Score: 1

NDC Code Structure

  • 0220 - Laboratoires Boiron
    • 0220-9332 - Sedalia

NDC 0220-9332-04

Package Description: 60 TABLET in 1 BLISTER PACK

NDC Product Information

Sedalia with NDC 0220-9332 is a a human over the counter drug product labeled by Laboratoires Boiron. The generic name of Sedalia is aconitum napellus, belladonna leaf, calendula officinalis flowering top, chelidonium majus, abrus precatorius seed, viburnum opulus root. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Laboratoires Boiron

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.

Sedalia 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.

  • ACONITUM NAPELLUS 6 [hp_C]/1
  • BELLADONNA LEAF 6 [hp_C]/1
  • CALENDULA OFFICINALIS FLOWERING TOP 6 [hp_C]/1
  • CHELIDONIUM MAJUS 6 [hp_C]/1
  • ABRUS PRECATORIUS SEED 6 [hp_C]/1
  • VIBURNUM OPULUS BARK 6 [hp_C]/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.

  • 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: 07-05-1997 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: 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.

Sedalia Product Label Images

Sedalia 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

Aconitum napellus 6C, Belladona 6C, Calendula officinalis 6C, Chelidonium majus 6C, Jequirity 6C, Viburnum opulus 6C

Otc - Purpose

Aconitum napellus 6C Relieves restlessness, agitation

Belladona 6C Relieves hypersensitivity to stress

Calendula officinalis 6C Relieves nervous fatigue, hypersensitivity to noise

Chelidonium majus 6C Relieves digestive symptoms caused by stress

Jequirity 6C Relieves uneasiness

Viburnum opulus 6C Relieves nervousness and restless sleep

Indications & Usage

For temporary relief of nervousness, hypersensitivity and irritability due to stress.

Otc - Stop Use

Stop use and ask a doctor if symptoms persist continuously for more than 2 weeks or worsen.

Otc - Ask Doctor

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

Otc - When Using

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Description

Directions: (adults and children 12 years of age and older):
Allow 3 tablets to dissolve in the mouth 3 times a day.

Storage And Handling

Store at 68-77


o F (20-25


o C)

Drug Interactions

Non habit forming, no drug interactions

Inactive Ingredient

Croscarmellose sodium, lactose, magnesium stearate.

Otc - Questions

Questions, Comments



www.boironusa.com



info@boironusa.com



1-800-BOIRON-1



(1-800-264-7661)



Boiron Information Center



6 campus Bouelvard



Newtown Square, PA



19073-3267

How Supplied

60 tablets

Dosage & Administration

Adult and children 12 years of age and older: dissolve 2 tablets in the mouth 3 times a day.

* Please review the disclaimer below.

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