NDC 62106-1056 Kalium Sulfuricum 6x

Potassium Sulfate

NDC Product Code 62106-1056

NDC CODE: 62106-1056

Proprietary Name: Kalium Sulfuricum 6x 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: Potassium Sulfate 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):
7 MM
Score: 1

NDC Code Structure

  • 62106 - Seroyal Usa

NDC 62106-1056-2

Package Description: 1 BOTTLE, GLASS in 1 CARTON > 100 TABLET in 1 BOTTLE, GLASS

NDC Product Information

Kalium Sulfuricum 6x with NDC 62106-1056 is a a human over the counter drug product labeled by Seroyal Usa. The generic name of Kalium Sulfuricum 6x is potassium sulfate. The product's dosage form is tablet and is administered via sublingual 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.

Kalium Sulfuricum 6x 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.

  • ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • XYLITOL (UNII: VCQ006KQ1E)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Sublingual - Administration beneath the tongue.

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: 05-03-2018 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.

Kalium Sulfuricum 6x Product Label Images

Kalium Sulfuricum 6x 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 ingredients

Kalium Sulphuricum (Potassium sulfate) 6X

Otc - Purpose

Uses

For the temporary relief of minor symptoms associated with minor skin irritation.

Warnings

Warnings

Do not use if you ever had an allergic reaction to this product or any of its ingredients.

Stop use and ask a doctor if symptoms persist or worsen.

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. In case of overdose, get medical help or contact a

Poison Control Center right away.

Otc - Stop Use

Stop use and ask a doctor if symptoms persist or worsen.

Other Safety Information

Other information

Do not use if seal is missing or broken.

Store in a cool, dry place.

Inactive Ingredient

Inactive ingredients

Lactose monohydrate (milk), magnesium stearate, sodium carboxymethylcellulose, xylitol

Dosage & Administration

Directions

Tip bottle slightly allowing for tablets to fall into the cap.

Use cap to drop tablets into mouth and allow them to dissolve under the tongue.

Adults and adolescents (12 years and older)
Take 1 to 4 tablets, one to four times daily, or as recommended by your healthcare practitioner.Children (under 12 years) Take under the direction of your healthcare practitioner.

Indications & Usage

Uses

For the temporary relief of minor symptoms associated with minor skin irritation.
Directions

Tip bottle slightly allowing for tablets to fall into the cap.

Use cap to drop tablets into mouth and allow them to dissolve under the tongue.

Adults and adolescents (12 years and older)
Take 1 to 4 tablets, one to four times daily, or as recommended by your healthcare practitioner.Children (under 12 years) Take under the direction of your healthcare practitioner.

* Please review the disclaimer below.