NDC 0220-9321 Roxalia

Arnica Montana, Arisaema Triphyllum Root, Belladonna Leaf, Bromine, Bryonia Alba Root, Mercurius Solubilis, Phytolacca Americana Root, Pulsatilla Vulgaris, Spongia Officinalis Skeleton, Roasted

  1. Labeler Index
  2. Laboratoires Boiron
  3. NDC: 0220-9321 Roxalia

NDC Product Code 0220-9321

NDC CODE: 0220-9321

Proprietary Name: Roxalia 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: Arnica Montana, Arisaema Triphyllum Root, Belladonna Leaf, Bromine, Bryonia Alba Root, Mercurius Solubilis, Phytolacca Americana Root, Pulsatilla Vulgaris, Spongia Officinalis Skeleton, Roasted 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 0220-9321-04

Package Description: 60 TABLET in 1 BLISTER PACK

NDC Product Information

Roxalia with NDC 0220-9321 is a a human over the counter drug product labeled by Laboratoires Boiron. The generic name of Roxalia is arnica montana, arisaema triphyllum root, belladonna leaf, bromine, bryonia alba root, mercurius solubilis, phytolacca americana root, pulsatilla vulgaris, spongia officinalis skeleton, roasted. 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.

Roxalia 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.
  • ARNICA MONTANA 3 [hp_C]/1
  • ARISAEMA TRIPHYLLUM ROOT 3 [hp_C]/1
  • BELLADONNA LEAF 3 [hp_C]/1
  • BROMINE 3 [hp_C]/1
  • BRYONIA ALBA ROOT 3 [hp_C]/1
  • MERCURIUS SOLUBILIS 4 [hp_C]/1
  • PHYTOLACCA AMERICANA ROOT 3 [hp_C]/1
  • PULSATILLA VULGARIS 3 [hp_C]/1
  • SPONGIA OFFICINALIS SKELETON, ROASTED 3 [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: 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 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.

Roxalia Product Label Images

Roxalia 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

Arnica montana 3C,
Arum triphyllum 3C,
Belladonna 3C,
Bromium 3C,
Bryonia alba 3C,
Mercuris solubilis 4C,
Phytolacca decandra 3C,
Pulsatilla 3C,
Spongia tosta 3C

Otc - Purpose

Arnica montana 3C Relieves hoarseness due to overexertion of the vocal cords



Arum triphyllum 3C Relieves vocal cord fatigue in speakers and singers



Belladonna 3C Relieves red and sore throat



Bromium 3C Relieves swollen and painful tonsils



Bryonia alba 3C Relieves sore throat with intense thirst



Mercuris solubilis 4C Relieves sore throat with intense salivation



Phytolacca decandra 3C Relieves sore throat with pain spreading to the ears



Pulsatilla 3C Relieves raw sore throat



Spongia tosta 3C Relieves hoarseness with dry throat

Indications & Usage

Temporary relieves minor sore throat and hoarseness.

Otc - Stop Use

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

Otc - Ask Doctor

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



If sore throat is severe, accompanied or followed by fever, headache, rash nausea or vomiting.

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

Dosage & Administration

Adults and children 12 years of age and older:
At the onset of symptoms, dissolve 2 tablets under the tongue every 15 minutes for 1 hour.
Then, dissolve 2 tablets under the tongue 3 times a day until symptoms are relieved.




Children under 12 years of age: Ask a doctor.

Storage And Handling

Store at 68-77


o F (20-25


o C)

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)



Distributed by Boiron Inc.



6 campus boulevard



Newtown Square, PA



19073-3267

How Supplied

60 tablets

* Please review the disclaimer below.