NDC 62106-1152 Unda 12

Argentum Metallicum, Aurum Metallicum, Dulcamara, Fagopyrum Esculentum, Illicium Verum, Lappa Major, Salvia Officinalis, Sarsaparilla, Staphysagria, Viola Tricolor

NDC Product Code 62106-1152

NDC Code: 62106-1152

Proprietary Name: Unda 12 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: Argentum Metallicum, Aurum Metallicum, Dulcamara, Fagopyrum Esculentum, Illicium Verum, Lappa Major, Salvia Officinalis, Sarsaparilla, Staphysagria, Viola Tricolor 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

  • 62106 - Seroyal Usa
    • 62106-1152 - Unda 12

NDC 62106-1152-8

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

NDC Product Information

Unda 12 with NDC 62106-1152 is a a human over the counter drug product labeled by Seroyal Usa. The generic name of Unda 12 is argentum metallicum, aurum metallicum, dulcamara, fagopyrum esculentum, illicium verum, lappa major, salvia officinalis, sarsaparilla, staphysagria, viola tricolor. 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 12 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.

  • GOLD 12 [hp_X]/20mL
  • SOLANUM DULCAMARA TOP 4 [hp_X]/20mL
  • FAGOPYRUM ESCULENTUM 4 [hp_X]/20mL
  • STAR ANISE FRUIT 4 [hp_X]/20mL
  • ARCTIUM LAPPA ROOT 4 [hp_X]/20mL
  • SAGE 4 [hp_X]/20mL
  • SARSAPARILLA 4 [hp_X]/20mL
  • DELPHINIUM STAPHISAGRIA SEED 12 [hp_X]/20mL
  • SILVER 12 [hp_X]/20mL
  • VIOLA TRICOLOR 4 [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.

  • ALCOHOL (UNII: 3K9958V90M)
  • WATER (UNII: 059QF0KO0R)
  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)
  • ALCOHOL (UNII: 3K9958V90M)
  • WATER (UNII: 059QF0KO0R)
  • 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: 09-21-2015 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: 12-31-2019 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.

Unda 12 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 ingredientsEach drop contains:Argentum metallicum (Silver) 12X

Aurum metallicum (Gold) 12X

Dulcamara (Bittersweet) Shoots 4X

Fagopyrum esculentum Aerial Parts 4X

Illicium verum (Star Anise) Fruit 4X

Lappa major (Great burdock) Root 4X

Salvia officinalis (Garden sage) Leaf 4X

Sarsaparilla Root 4X

Staphysagria (Stavesacre) Seed 12X

Viola tricolor (Pansy) Aerial Parts 4X

Active ingredientsEach drop contains:Absinthium (Common wormwood) Aerial Parts 4X

Aconitum napellus (Aconite) Whole Plant 4X

Argentum metallicum (Silver) 12X

Boldo Leaf 4X

Chamomilla (German chamomile) Whole Flowering Plant 4X

Coffea tosta (Roasted coffee) Seed 4X

Jateorhiza palmata (Columbo) Root 4X

Manganum oxydatum nigrum (Manganese dioxide) 12X

Salvia officinalis (Garden sage) Leaf 4X

Active ingredientsEach drop contains:

Argentum metallicum (Silver) 12X

Crataegus (Hawthorn) Fruit 4X

Gelsemium sempervirens (Yellow jessamine) Underground Parts 4X

Hamamelis virginiana (Witch hazel) Bark 4X

Magnolia grandiflora Flower 4X

Spiraea ulmaria (Queen-of-the-meadow) Underground Parts 4X

Stannum metallicum (Tin) 12X

Valeriana officinalis (Valerian) Root 4X

Active ingredientsEach drop contains:

Antimonium crudum (Antimonous sulfide) 12X

Borago officinalis (Common borage) Leaf 4X

Cetraria islandica (Iceland moss) Whole Plant 4X

Drosera (Sundew) Whole Plant 4X

Mentha piperita (Peppermint) Aerial Parts 4X

Senega officinalis (Snakeroot) Root 4X

Otc - Purpose

UsesFor the temporary relief of symptoms associated with mild skin irritation.

Uses

For the temporary relief of symptoms associated with mild anxiousness and nervousness.

Uses

For the temporary relief of symptoms associated with

coldness or numbness of the extremities.

Uses

For the relief of symptoms associated with laryngitis and voice hoarseness.

Warnings

WarningsStop 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.

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.

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.

WarningsAsk a doctor before use if you have Persistent cough or chronic cough

such as occurs with smoking, asthma, chronic bronchitis, or emphysema and Cough that is accompanied by

excessive phlegm (mucus) or fever.
Stop use and ask a doctor if symptoms persist or worsen and Cough persists for more than 1 week,

tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

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 - Stop Use

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

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

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

Stop use and ask a doctor if symptoms persist or worsen and Cough persists for more than 1 week,tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

Otc - Pregnancy Or Breast Feeding

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

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

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

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Keep out of reach of children.

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.

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

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

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

Inactive Ingredient

Inactive ingredients

Ethanol (beet), purified water

Inactive ingredients

Ethanol (beet), purified water

Inactive ingredients

Ethanol (beet), purified water

Inactive ingredients

Ethanol (beet), purified water

Other Safety Information

Other informationDo not use if seal is missing or broken.Store in a cool, dry place.

Other information

Do not use if seal is missing or broken.

Store in a cool, dry place.

Other information

Do not use if seal is missing or broken.

Store in a cool, dry place.

Other information

Do not use if seal is missing or broken.

Store in a cool, dry place.

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.

Directions

Adults 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.

Directions

Adults 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.

Directions

Adults 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.

Indications & Usage

UsesFor the temporary relief of symptoms associated with mild skin irritation.Directions

Adults 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.

Uses

For the temporary relief of symptoms associated with mild anxiousness and nervousness.
Directions

Adults 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.

Uses

For the temporary relief of symptoms associated with

coldness or numbness of the extremities.
Directions

Adults 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.

Uses

For the relief of symptoms associated with laryngitis and voice hoarseness.
Directions

Adults 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 - Ask Doctor

Ask a doctor before use if you have Persistent cough or chronic cough

such as occurs with smoking, asthma, chronic bronchitis, or emphysema and Cough that is accompanied by

excessive phlegm (mucus) or fever.

* Please review the disclaimer below.

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