NDC 59469-319 Upelva

Cyclamen Purpurascens Tuber, Chamaelirium Luteum Root, Hypericum Perforatum, Potassium Carbonate, Delphinium Staphisagria Seed, Datura Stramonium Flowering Top, Viburnum Opulus Bark, And Zanthoxylum Americanum Bark

NDC Product Code 59469-319

NDC Code: 59469-319

Proprietary Name: Upelva 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: Cyclamen Purpurascens Tuber, Chamaelirium Luteum Root, Hypericum Perforatum, Potassium Carbonate, Delphinium Staphisagria Seed, Datura Stramonium Flowering Top, Viburnum Opulus Bark, And Zanthoxylum Americanum Bark 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.

NDC Code Structure

  • 59469 - Pekana Naturheilmittel Gmbh
    • 59469-319 - Upelva

NDC 59469-319-10

Package Description: 1 BOTTLE, GLASS in 1 BOX > 50 mL in 1 BOTTLE, GLASS

NDC Product Information

Upelva with NDC 59469-319 is a a human over the counter drug product labeled by Pekana Naturheilmittel Gmbh. The generic name of Upelva is cyclamen purpurascens tuber, chamaelirium luteum root, hypericum perforatum, potassium carbonate, delphinium staphisagria seed, datura stramonium flowering top, viburnum opulus bark, and zanthoxylum americanum bark. The product's dosage form is solution/ drops and is administered via oral form.

Labeler Name: Pekana Naturheilmittel Gmbh

Dosage Form: Solution/ Drops - A solution which is usually administered in a drop-wise fashion.

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.

Upelva 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.

  • CYCLAMEN PURPURASCENS TUBER 3 [hp_X]/50mL
  • CHAMAELIRIUM LUTEUM ROOT 4 [hp_X]/50mL
  • HYPERICUM PERFORATUM 3 [hp_X]/50mL
  • POTASSIUM CARBONATE 4 [hp_X]/50mL
  • DELPHINIUM STAPHISAGRIA SEED 6 [hp_X]/50mL
  • DATURA STRAMONIUM FLOWERING TOP 10 [hp_X]/50mL
  • VIBURNUM OPULUS BARK 1 [hp_X]/50mL
  • ZANTHOXYLUM AMERICANUM BARK 3 [hp_X]/50mL

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.

  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)

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: Pekana Naturheilmittel Gmbh
Labeler Code: 59469
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: 06-24-2019 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.

Upelva 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

Ingredients:Cyclamen europaeum3XDatura stramonium (Stramonium)10XDelphinium staphysagria (Staphisagria)6XChamaelirium luteum (Helonias dioica)4XHypericum perforatum3XKalium carbonicum4XZanthoxylum fraxineum (Xanthoxylum fraxineum)3XViburnum opulus1XSelected ingredients prepared by spagyric processes.

Inactive Ingredient

Contains 44% alcohol by volume.

Otc - Purpose

For relief of minor menstrual pain. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated.

Dosage

Unless otherwise prescribed, adults take 15-20 drops, 3 times per day. For pediatric dosages, consult your practitioner.

Warning

If symptoms persist, contact a licensed practitioner. If you have known sensitivity to any of the ingredients, please consult your licensed practitioner before use. If you are pregnant or nursing a baby, seek the advice of a health care professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children.

Storage And Handling

Protect from light and heat.

Tamper Evident

Do not use this product if tamper evident strip is broken or removed from base of cap.

Otc - Questions

To report adverse events, contact BioResource at 321B Blodgett Street, Cotati, CA 94931

Other

Distributed by:BioResource Inc.Cotati, CA 94931Manufactured by:PEKANA® GmbHD-88353 Kisslegg

* Please review the disclaimer below.

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