NDC 62106-1100 Unda 1

Achillea Millefolium

NDC Product Code 62106-1100

NDC 62106-1100-8

Package Description: 1 BOTTLE in 1 CARTON > 20 mL in 1 BOTTLE

NDC Product Information

Unda 1 with NDC 62106-1100 is a a human over the counter drug product labeled by Seroyal Usa. The generic name of Unda 1 is achillea millefolium. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Seroyal Usa

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Unda 1 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.

  • ACHILLEA MILLEFOLIUM 4 [hp_X]/20mL
  • ARCTOSTAPHYLOS UVA-URSI LEAF 4 [hp_X]/20mL
  • VALERIAN 4 [hp_X]/20mL
  • ANGELICA ARCHANGELICA ROOT 4 [hp_X]/20mL
  • EQUISETUM ARVENSE TOP 4 [hp_X]/20mL
  • LYCOPODIUM CLAVATUM SPORE 4 [hp_X]/20mL
  • LARIX DECIDUA RESIN 5 [hp_X]/20mL
  • SILVER 12 [hp_X]/20mL

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: 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: 07-01-2014 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.

Unda 1 Product Label Images

Unda 1 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 - Purpose

Uses

For the temporary relief of symptoms associated with

indigestion

fatigue following meals

occasional headaches

Warnings

Warnings

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 - Keep Out Of Reach Of Children

Keep out of reach of children.

Otc - Active Ingredient

Active ingredients

Each drop contains:

Angelica archangelica (European angelica) Root 4X

Argentum metallicum (Silver) 12X

Equisetum arvense (Common horsetail) Stem 4X

Lycopodium clavatum (Clubmoss) Spore 4X

Millefolium (Yarrow) Aerial Parts 4X

Resina larcis (Larch turnpentine) Balsam 5X

Uva-ursi (Bearberry) Leaf 4X

Valeriana officinalis (Valerian) Root 4X

Inactive Ingredient

Inactive ingredients

Ethanol (beet), purified water

Indications & Usage

Uses

For the temporary relief of symptoms associated with

indigestion

fatigue following meals

occasional headaches
DirectionsAdults and adolescents (12 years and older)Take 5 drops three times daily or as recommended by your healthcare practitioner.Children (under 12 years)Take under the direction of your healthcare practitioner.

Dosage & Administration

DirectionsAdults and adolescents (12 years and older)Take 5 drops three times daily or as recommended by your healthcare practitioner.Children (under 12 years)Take under the direction of your healthcare practitioner.

Otc - Stop Use

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

Other Safety Information

Do not use if seal is missing or broken.Store in a cool dry place.

* Please review the disclaimer below.