NDC 54532-0015 Hevert Cough Relief

Drosera Rotundifolia, Drosera Intermedia, Drosera Anglica, Eriodictyon Californicum Flowering Top, Grindelia Hirsutula Flowering Top, Potassium Iodide, Spongia Officinalis Skeleton, Roasted, Lobaria Pulmonaria, Teucrium Scorodonia Flowering Top, And Verbascum Densiflorum Flowering Top

NDC Product Code 54532-0015

NDC CODE: 54532-0015

Proprietary Name: Hevert Cough 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: Drosera Rotundifolia, Drosera Intermedia, Drosera Anglica, Eriodictyon Californicum Flowering Top, Grindelia Hirsutula Flowering Top, Potassium Iodide, Spongia Officinalis Skeleton, Roasted, Lobaria Pulmonaria, Teucrium Scorodonia Flowering Top, And Verbascum Densiflorum Flowering Top 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Potassium iodide is used to loosen and break up mucus in the airways. This helps you cough up the mucus so you can breathe more easily if you have long-term lung problems (e.g., asthma, chronic bronchitis, emphysema). This medication is known as an expectorant. Potassium iodide is also used along with antithyroid medicines to prepare the thyroid gland for surgical removal, to treat certain overactive thyroid conditions (hyperthyroidism), and to protect the thyroid in a radiation exposure emergency. It works by shrinking the size of the thyroid gland and decreasing the amount of thyroid hormones produced. In a radiation emergency, potassium iodide blocks only the thyroid from absorbing radioactive iodine, protecting it from damage and reducing the risk of thyroid cancer. Use this medication along with other emergency measures that will be recommended to you by public health and safety officials (e.g., finding safe shelter, evacuation, controlling food supply).

Product Characteristics

Color(s):
WHITE (C48325)
Shape: ROUND (C48348)
Size(s):
9 MM
Imprint(s):
H
Score: 1

NDC Code Structure

  • 54532 - Hevert Pharmaceuticals Llc

NDC 54532-0015-4

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

NDC Product Information

Hevert Cough Relief with NDC 54532-0015 is a a human over the counter drug product labeled by Hevert Pharmaceuticals Llc. The generic name of Hevert Cough Relief is drosera rotundifolia, drosera intermedia, drosera anglica, eriodictyon californicum flowering top, grindelia hirsutula flowering top, potassium iodide, spongia officinalis skeleton, roasted, lobaria pulmonaria, teucrium scorodonia flowering top, and verbascum densiflorum flowering top. 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 Cough 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.

  • DROSERA ROTUNDIFOLIA 4 [hp_X]/1
  • DROSERA INTERMEDIA 4 [hp_X]/1
  • DROSERA ANGLICA 4 [hp_X]/1
  • ERIODICTYON CALIFORNICUM FLOWERING TOP 2 [hp_X]/1
  • GRINDELIA HIRSUTULA FLOWERING TOP 4 [hp_X]/1
  • POTASSIUM IODIDE 3 [hp_X]/1
  • SPONGIA OFFICINALIS SKELETON, ROASTED 4 [hp_X]/1
  • LOBARIA PULMONARIA 3 [hp_X]/1
  • TEUCRIUM SCORODONIA FLOWERING TOP 3 [hp_X]/1
  • VERBASCUM DENSIFLORUM FLOWERING TOP 2 [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: 03-07-2013 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.

Hevert Cough Relief Product Label Images

Hevert Cough 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, LLCBoulder, CO 80301

Otc - Purpose

Active ingredientsPurpose (Relief of)"X" indicates a homeopathic dilution. For more information visit: www.hevertusa.comDrosera 4XDry, irritating coughEriodictyon californicum 2XWet cough with phlegm and chest congestionGrindelia 4XChest congestionKali iodatum 3XWet cough with phlegm and chest congestionSpongia tosta 4XHoarseness and coughSticta pulmonaria 3XChronic respiratory conditionsTeucrium scorodonia 3XChronic respiratory conditionsVerbascum densiflorum 2XDry or hoarse cough

Uses

  • For temporary relief of cough and cold symptoms, such as:dry, irritating coughwet cough with phlegmchest congestionhoarsenessThese 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 iodine

Stop Use And Ask A Doctor If

  • You have a persistent or chronic cough such as occurs with, smoking, asthma, chronic bronchitis, or emphysema or if cough is accompanied by excessive phlegm (mucus).symptoms persist for more than 7 days, recur, or are accompanied by fever, rash, or headache.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, 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.

Directions

  • 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.To report serious adverse events, call 1-855-387-6466.

Inactive Ingredients

Lactose, magnesium stearate

Questions?

1-855-387-6466

* Please review the disclaimer below.