NDC 34666-311 Elderberry Up

Sambucus Nigra, Sulphur, Bryonia

NDC Product Code 34666-311

NDC CODE: 34666-311

Proprietary Name: Elderberry Up 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: Sambucus Nigra, Sulphur, Bryonia 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):
WHITE (C48325 - NONE)
Shape: ROUND (C48348)
Size(s):
10 MM
Imprint(s):
NONE
Score: 1

NDC Code Structure

  • 34666 - Nartex Laboratorios Homeopaticos Sa De Cv

NDC 34666-311-01

Package Description: 1 BLISTER PACK in 1 CARTON > 60 TABLET in 1 BLISTER PACK

NDC Product Information

Elderberry Up with NDC 34666-311 is a a human over the counter drug product labeled by Nartex Laboratorios Homeopaticos Sa De Cv. The generic name of Elderberry Up is sambucus nigra, sulphur, bryonia. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Nartex Laboratorios Homeopaticos Sa De Cv

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.

Elderberry Up 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.

  • SAMBUCUS NIGRA FLOWERING TOP 6 [hp_X]/1
  • SULFUR 12 [hp_X]/1
  • BRYONIA ALBA ROOT 6 [hp_X]/1

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)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • TALC (UNII: 7SEV7J4R1U)
  • GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
  • LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
  • STARCH, POTATO (UNII: 8I089SAH3T)
  • WATER (UNII: 059QF0KO0R)

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: Nartex Laboratorios Homeopaticos Sa De Cv
Labeler Code: 34666
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: 09-03-2020 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 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.

Elderberry Up Product Label Images

Elderberry Up 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

Sambucus Nigra 6x HPUS*Bryonia 6x HPUS*Sulphur 12x HPUS*The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. "X" is a homeopathic dilution. See www.nartexlabsusa.com for more information.

Purpose

Sambucus Nigra 6x HPUS*..............Nasal CongestionBryonia 6x HPUS*..............Nasal Congestion and antitussiveSulphur 12x HPUS*..............Nasal Congestion and anti-inflammatory

Uses

  • Temporarily relieves discomforting symptoms such as:runny nosesore throatcoughingsneezing and nasal congestionClaims based on traditional homeopathic practice, not accepted medical evidence. These uses have not been evaluated by FDA, and product has not been clinically tested.

Otc - Do Not Use

Do not use if you have if you have an allergy or hypersensitivity to the components of the formula or have had a prior reaction to this product.

Otc - Stop Use

Stop use and ask a doctor if- condition worsens- symptoms persist for more than 7 days or clear up and occur again within a few days.- rash develops

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

- adults and children 4 years of age and older: take 2 tablets every 6 hours.- children under 4 years of age, consult a physician.

Other Information

- store in a cool dry place. - do not use if blister pack is broken.

Inactive Ingredients

Gelatin, lactose, magnesium stearate, potato starch, purified water, sodum benzoate, talc

* Please review the disclaimer below.