NDC 52053-0001 Sambucol Cold And Flu Relief

Bryonia, Gelsemium Sempervirens, Sabucus Nigra, Sulphur, Zincum Gluconicum

NDC Product Code 52053-0001

NDC CODE: 52053-0001

Proprietary Name: Sambucol Cold And Flu Relief 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: Bryonia, Gelsemium Sempervirens, Sabucus Nigra, Sulphur, Zincum Gluconicum 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

NDC 52053-0001-2

Package Description: 2 BLISTER PACK in 1 CARTON > 4500 mg in 1 BLISTER PACK (52053-0001-1)

NDC 52053-0001-4

Package Description: 6 BLISTER PACK in 1 CARTON > 4500 mg in 1 BLISTER PACK

NDC Product Information

Sambucol Cold And Flu Relief with NDC 52053-0001 is a a human over the counter drug product labeled by Pharmacare Us, Inc.. The generic name of Sambucol Cold And Flu Relief is bryonia, gelsemium sempervirens, sabucus nigra, sulphur, zincum gluconicum. The product's dosage form is tablet, orally disintegrating and is administered via oral form.

Dosage Form: Tablet, Orally Disintegrating - A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue.

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.

Sambucol Cold And Flu Relief 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.

  • BLACK CARROT ANTHOCYANINS (UNII: 971DA56IOL)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • LACTOSE (UNII: J2B2A4N98G)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • SUCROSE (UNII: C151H8M554)
  • EUROPEAN ELDERBERRY JUICE (UNII: Z4IFJ0AK1E)

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: Pharmacare Us, Inc.
Labeler Code: 52053
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: 10-15-2021 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: 12-31-2022 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.

Sambucol Cold And Flu Relief Product Label Images

Sambucol Cold And Flu Relief 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

Active Ingredients:

Bryonia 6X, Gelsemium Sempervirens 6X, 12X, 30X, Sambucus Nigra 3X, 6X, Sulphur 12X, Zincum Gluconicum 2X, 6X.

Indications:

• Temporarily relieves cold and flu symptoms.• Provides temporary relief from respiratory symptoms such as sneezing, runny nose, nasal and sinus congestion, minor sore throat and   headache.• Also temporarily relieves fever, chills, and body aches associated with the flu.

• Temporarily relieves cold and flu symptoms.• Provides temporary relief from respiratory symptoms such as sneezing, runny nose, nasal and sinus congestion, minor sore throat andheadache.• Also temporarily relieves fever, chills, and body aches associated with the flu.

Warnings:

Sore throat warning - Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious.  Consult physician promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a physician. Stop use and ask a doctor if • Symptoms worsen. Any new symptoms appear. • Fever lasts for more than three days.• Respiratory symptoms persist for more than seven days. If pregnant or breast feeding ask a health professional before using.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Do not use if blister seal is broken.

Directions:

For best results, use at the first sign of symptoms of a cold or flu and continue to use for an additional 48 hours after symptoms subside. Adults and children 4 years of age and older. Dissolve entire tablet in mouth. Do not chew. Do not swallow whole. Take one tablet at the outset of symptoms. Repeat every three hours until symptoms are gone. Children under 4 years of age consult a doctor before use.

Inactive Ingredients:

Black Carrot Colorant, Natural, Croscarmellose Sodium, Elderberry Flavor, Natural, Lactose, Magnesium Stearate, Microcrystalline Cellulose, Sucrose

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.

Questions:

PharmaCare US Inc.P.O. Box 122950San Diego CA  92112Questions? Comments?Visit our websitewww.sambucolUSA.comor call 1-866-613-5057

Package Label Display:

NDC# 52053-0001-2SambucolBLACK ELDERBERRYCOLD & FLU RELIEFTAKE AT THE FIRSTSIGN OF COLD ANDFLU SYMPTOMSFast temporary relief from:Nasal & sinus congestionRunny noseSore ThroatCoughingSneezingChills & fever30 QUICK DISSOLVE TABLETSHOMEOPATHIC

* Please review the disclaimer below.