NDC 54532-0014 Hevert Pain Relief

Arnica Montana Root And Toxicodendron Pubescens Shoot

NDC Product Code 54532-0014

NDC CODE: 54532-0014

Proprietary Name: Hevert Pain 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: Arnica Montana Root And Toxicodendron Pubescens Shoot 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 54532-0014-4

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

NDC 54532-0014-5

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

NDC Product Information

Hevert Pain Relief with NDC 54532-0014 is a a human over the counter drug product labeled by Hevert Pharmaceuticals Llc. The generic name of Hevert Pain Relief is arnica montana root and toxicodendron pubescens shoot. 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.

Hevert Pain 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.

  • 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: 02-15-2013 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 - 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 Pain Relief Product Label Images

Hevert Pain 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"X" indicates a homeopathic dilution. For more information visit: www.hevertusa.comArnica montana, radix 4XMuscle pain and stiffness, bruising and swelling due to injuries and overexertionRhus toxicodendron 6XMuscle pain and stiffness, overexertion

Uses

  • For temporary relief of muscle pain and stiffnessReduces bruising and minor swelling due to injuries and overexertionThese 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 Arnica montana or other plants from the daisy family (Compositae)you are allergic to Rhus toxicodendron or other plants from the cashew family

Stop Use And Ask A Doctor If

  • Pain gets worse or lasts for more than 7 daysnew symptoms occurredness or swelling is presentThese could be signs of a serious condition.

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

  • 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.