NDC 0220-9324 Sabadil

Onion, Ambrosia Artemisiifolia, Histamine Dihydrochloride, Euphrasia Stricta, Schoenocaulon Officinale Seed, Solidago Virgaurea

NDC Product Code 0220-9324

NDC CODE: 0220-9324

Proprietary Name: Sabadil 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: Onion, Ambrosia Artemisiifolia, Histamine Dihydrochloride, Euphrasia Stricta, Schoenocaulon Officinale Seed, Solidago Virgaurea 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

NDC 0220-9324-04

Package Description: 60 TABLET in 1 BLISTER PACK

NDC Product Information

Sabadil with NDC 0220-9324 is a a human over the counter drug product labeled by Laboratoires Boiron. The generic name of Sabadil is onion, ambrosia artemisiifolia, histamine dihydrochloride, euphrasia stricta, schoenocaulon officinale seed, solidago virgaurea. 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.

Sabadil 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.

  • ONION 5 [hp_C]/1
  • AMBROSIA ARTEMISIIFOLIA 5 [hp_C]/1
  • HISTAMINE DIHYDROCHLORIDE 9 [hp_C]/1
  • EUPHRASIA STRICTA 5 [hp_C]/1
  • SCHOENOCAULON OFFICINALE SEED 5 [hp_C]/1
  • SOLIDAGO VIRGAUREA FLOWERING TOP 5 [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.
  • 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: 09-01-1997 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: 12-31-2020 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.

Sabadil Product Label Images

Sabadil 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

Allium cepa 5C, Ambrosia artemisiaefolia 5C, Histaminum hydrochloricum 9C, Euphrasia officinalis 5C, Sabadilla 5C, Soldigo virgaurea 5C

Indications & Usage

For temporary relief of one or more of these symptoms of hay fever or other upper respiratory allergies; itchy nose, sneezing, runny nose, and itchy and watery eyes.

Inactive Ingredient

Croscarmellose sodium, lactose, magnesium stearate.

How Supplied

60 tablets

Otc - Purpose

Allium cepa 5C HPUS Relieves runny nose associated with allergies


Ambrosia artemisiaefolia 5C HPUS Relieves spasmodic cough associated with hay fever


Histaminum hydrochloricum 9C HPUS relieves symptoms of allergic conditions


Euphrasia officinalis 5C HPUS Relieves burning, irritated eyes


Sabadilla 5C HPUS Relieves sneezing associated with allergies


Soldigo virgaurea 5C HPUS Relieves abundant nasal discharge

Storage And Handling

Store at 68-77


o F (20-25


o C)

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

Otc - Ask Doctor

Ask a doctor before use in children younger than 2 years of age.

Otc - Stop Use

Stop use and ask a doctor if symptoms persist continuously for more than 7 days or worsen.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Otc - When Using

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

Drug Interactions

Non drowsy, no drug interactions

Dosage & Administration

Adults and children 2 years of age and older: At the onset of symptoms, dissolve 2 tablets in the mouth every 15 minutes for 1 hour. Then, dissolve 2 tablets in the mouth 3 times a day until symptoms are relieved.

* Please review the disclaimer below.