NDC 62106-4927 Bromium

Bromine

NDC Product Code 62106-4927

NDC 62106-4927-4

Package Description: 10 TUBE in 1 CARTON > 140 GRANULE in 1 TUBE

NDC Product Information

Bromium with NDC 62106-4927 is a a human over the counter drug product labeled by Seroyal Usa. The generic name of Bromium is bromine. The product's dosage form is granule and is administered via oral form.

Labeler Name: Seroyal Usa

Dosage Form: Granule - A small particle or grain.

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.

Bromium 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.

  • BROMINE 6 [hp_X]/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.

  • SUCROSE (UNII: C151H8M554)
  • LACTOSE (UNII: J2B2A4N98G)

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: Seroyal Usa
Labeler Code: 62106
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: 12-09-2015 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.

Bromium Product Label Images

Bromium 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

Active ingredientsBROMIUM 200K GRBROMIUM 6CH GR

Otc - Purpose

IndicationsFor the temporary relief of coughs, migraines, and

sore throats

Warnings

Warning:

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdosage

In case of overdose, get medical help or contact a Poison Control Center right away.

Inactive Ingredient

Inactive Ingredients

Lactose,

sucrose.

Dosage & Administration

Directions

Adults: Take five granules three times daily or as recommended by your healthcare practitioner.

Children: Take three granules and follow adult directions.

Indications & Usage

IndicationsFor the temporary relief of coughs, migraines, and

sore throats
Directions

Adults: Take five granules three times daily or as recommended by your healthcare practitioner.

Children: Take three granules and follow adult directions.

Otc - Questions

QUESTIONS? 1-888-737-6925.

* Please review the disclaimer below.