NDC 54532-0022 Hevert Sinus Relief

Apis Mellifera, Baptisia Tinctoria, Echinacea, Unspecified, Calcium Sulfide, Potassium Dichromate, Lachesis Muta Venom, Luffa Operculata Fruit, Mercuric Iodide, Mercuric Sulfide, Silicon Dioxide, And Spongia Officinalis Skeleton, Roasted

NDC Product Code 54532-0022

NDC CODE: 54532-0022

Proprietary Name: Hevert Sinus 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: Apis Mellifera, Baptisia Tinctoria, Echinacea, Unspecified, Calcium Sulfide, Potassium Dichromate, Lachesis Muta Venom, Luffa Operculata Fruit, Mercuric Iodide, Mercuric Sulfide, Silicon Dioxide, And Spongia Officinalis Skeleton, Roasted 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)
Shape: ROUND (C48348)
Size(s):
9 MM
Imprint(s):
H
Score: 1

NDC Code Structure

NDC 54532-0022-4

Package Description: 10 BLISTER PACK in 1 CARTON > 10 TABLET in 1 BLISTER PACK

NDC 54532-0022-5

Package Description: 2 BLISTER PACK in 1 CARTON > 10 TABLET in 1 BLISTER PACK

NDC Product Information

Hevert Sinus Relief with NDC 54532-0022 is a a human over the counter drug product labeled by Hevert Pharmaceuticals Llc. The generic name of Hevert Sinus Relief is apis mellifera, baptisia tinctoria, echinacea, unspecified, calcium sulfide, potassium dichromate, lachesis muta venom, luffa operculata fruit, mercuric iodide, mercuric sulfide, silicon dioxide, and spongia officinalis skeleton, roasted. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Hevert Pharmaceuticals Llc

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.

Hevert Sinus 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.

  • APIS MELLIFERA 4 [hp_X]/1
  • BAPTISIA TINCTORIA 4 [hp_X]/1
  • ECHINACEA, UNSPECIFIED 2 [hp_X]/1
  • CALCIUM SULFIDE 4 [hp_X]/1
  • POTASSIUM DICHROMATE 8 [hp_X]/1
  • LACHESIS MUTA VENOM 8 [hp_X]/1
  • LUFFA OPERCULATA FRUIT 6 [hp_X]/1
  • MERCURIC IODIDE 9 [hp_X]/1
  • MERCURIC SULFIDE 6 [hp_X]/1
  • SILICON DIOXIDE 2 [hp_X]/1
  • SPONGIA OFFICINALIS SKELETON, ROASTED 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.

  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)

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: Hevert Pharmaceuticals Llc
Labeler Code: 54532
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: 07-01-2015 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: 12-31-2021 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.

Hevert Sinus 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

Other

Drug Facts

Distributed by:Hevert Pharmaceuticals, LLCEugene, OR 97401

Otc - Purpose

Active ingredientsPurpose"X" indicates a homeopathic dilution. For more information visit: www.hevertusa.comApis mellifica 4XAll ingredients relieve sinus and nasal congestionBaptisia tinctoria 4XEchinacea 2XHepar sulphuris calcareum 4XKali bichromicum 8XLachesis mutus 8XLuffa operculata 6XMercurius iodatus ruber 9XMercurius sulphuratus ruber 6XSilicea 2XSpongia tosta 6X

Uses

  • For temporary relief of:nasal congestionsinus congestionsinus pressurerunny nosesneezingThese statements have not been evaluated by the Food and Drug Administration. They are supported by traditional homeopathic principles.

Do Not Use If

  • You are allergic to bee venom or to Echinacea or other plants from the daisy family (Compositae)

Stop Use And Ask A Doctor If

  • Hypersalivation or skin reactions occur after usesymptoms are accompanied by fever, persist, worsen or if new symptoms occur.In the event of severe allergic reactions, consult a doctor immediately.

Otc - Pregnancy Or Breast Feeding

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

Otc - 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.

Directions

  • For best results, use at the first sign of symptoms and continue to use for an additional 48 hours after symptoms subside.Adults and children over 12 years of age: Dissolve 2 tablets in mouth 3 times daily. In acute cases, dissolve 2 tablets in mouth 6 times daily.Children 6 to 12 years of age: Dissolve 1 tablet in mouth 3 times daily. In acute cases, dissolve 1 tablet in mouth 6 times daily.

Other Information

  • Store at 68 to 77 °F.Tamper Evident: Do not use if blister seal is broken.

Inactive Ingredients

Lactose, magnesium stearate

Questions?

1-855-387-6466

* Please review the disclaimer below.