NDC 0363-6886 Walgreens Black Elderberry Cold And Flu Relief

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

NDC Product Code 0363-6886

NDC CODE: 0363-6886

Proprietary Name: Walgreens Black Elderberry 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, Sambucus 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.

Product Characteristics

Color(s):
PURPLE (C48327 - (OFF PURPLE OFF GREY COLOR WITH SPECKS) )
Shape: ROUND (C48348)
Size(s):
10 MM
Flavor(s):
BERRY (C73365 - (ELDERBERRY))

NDC Code Structure

  • 0363 - Walgreen Company
    • 0363-6886 - Walgreens Black Elderberry Cold And Flu Relief

NDC 0363-6886-14

Package Description: 1 BLISTER PACK in 1 CARTON > 30 TABLET in 1 BLISTER PACK

NDC Product Information

Walgreens Black Elderberry Cold And Flu Relief with NDC 0363-6886 is a a human over the counter drug product labeled by Walgreen Company. The generic name of Walgreens Black Elderberry Cold And Flu Relief is bryonia, gelsemium sempervirens, sambucus nigra, sulphur, zincum gluconicum. The product's dosage form is tablet and is administered via oral 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.

Walgreens Black Elderberry 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.

  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • SUCROSE (UNII: C151H8M554)
  • BLACK CARROT ANTHOCYANINS (UNII: 971DA56IOL)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • 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.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Walgreen Company
Labeler Code: 0363
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: 06-15-2021 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.

Walgreens Black Elderberry Cold And Flu Relief Product Label Images

Walgreens Black Elderberry 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

Drug Facts

Drug Facts

Active Ingredients

Active ingredients (In each tablet) *PurposeBryonia 6X HPUSFever, chills, scratchy throat, muscle sorenessGelsemium sempervirens 6X, 12X, 30X HPUSSneezing, non-productive cough, bronchial irritationSambucus nigra 3X, 6X HPUSFever, nasal congestion, coughingSulphur 12X HPUSSinus pressure, sore throat, nasal pressureZincum gluconicum 2X, 6X HPUSNausea, tiredness, exhaustion, bronchial constriction*The letters ‘HPUS’ indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Purpose

Bryonia - Fever, chills, scratchy throat, muscle sorenessGelsemium sempervirens - Sneezing, non-productive cough, bronchial irritationSambucus nigra - Fever, nasal congestion, coughingSulphur - Sinus pressure, sore throat, nasal pressureZincum gluconicum - Nausea, tiredness, exhaustion, bronchial constriction

Uses*

According to homeopathic indications, these ingredients provide temporary relief of cold and flu symptoms such as: • Nasal and sinus congestion, runny nose, sore throat, coughing, sneezing, and chills and fever, after serious causes have been ruled out by a physician.* These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Warnings

WarningsA PHYSICIAN SHOULD ALWAYS BE CONSULTED TO RULE OUT SERIOUS CAUSES.
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 4 years of age unless directed by a physician. • This product is intended to complement, not replace, standard medical treatment. • Initial worsening of symptoms may occur.

Pregnant Or Breast-Feeding


If pregnant or breast-feeding, ask a health professional before use.

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.

Stop Use And Ask A Doctor

Stop use and ask a doctor if:• You experience worsening symptoms. • Any new symptoms appear. • Symptoms last longer than 7 days.

Directions

Directions• Suitable for adults and children ages 4 and over. Children under the age of 4: Consult a physician before use. • For best results, take at the start of the symptoms for cold or flu and continue to take for another 48 hours after the symptoms end. • Dissolve entire tablet under tongue OR chew tablet and swallow. • Do not swallow tablet whole. • Take 1 tablet every three hours. • Take at least 10 minutes before or at least 10 minutes after eating or drinking. • Homeopathic remedies may not be effective for everyone. Individual results may vary.

Other Information

Other information• Do not use if blister seal is broken. • Store at room temperature 15o to 30o C (59o to 86o F). • Active ingredients are micro-diluted in accordance with the Homeopathic Pharmacopoeia of the United States and are therefore non-toxic with no known side effects or contraindications. • Retain carton for full drug facts.

Inactive Ingredients

Inactive ingredientsBlack carrot extract (colorant), Croscarmellose sodium, Elderberry flavor, Lactose, Magnesium stearate, Maltodextrin, Microcrystalline cellulose, Sucrose.

* Please review the disclaimer below.