NDC 48951-3136 Crataegus Onopordon

Crataegus Onopordon

NDC Product Code 48951-3136

NDC 48951-3136-3

Package Description: 60 mL in 1 BOTTLE, DROPPER

NDC Product Information

Crataegus Onopordon with NDC 48951-3136 is a a human over the counter drug product labeled by Uriel Pharmacy Inc.. The generic name of Crataegus Onopordon is crataegus onopordon. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Uriel Pharmacy Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Crataegus Onopordon 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.

  • ONOPORDUM ACANTHIUM FLOWER 2 [hp_X]/mL
  • PRIMULA VERIS FLOWER 2 [hp_X]/mL
  • HYOSCYAMUS NIGER LEAF 3 [hp_X]/mL
  • HAWTHORN LEAF WITH FLOWER 3 [hp_X]/mL
  • SELENICEREUS GRANDIFLORUS STEM 4 [hp_X]/mL
  • BEEF HEART 6 [hp_X]/mL
  • GOLD 15 [hp_X]/mL

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.

  • WATER (UNII: 059QF0KO0R)
  • PROPOLIS WAX (UNII: 6Y8XYV2NOF)

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: Uriel Pharmacy Inc.
Labeler Code: 48951
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: 09-01-2009 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.

Crataegus Onopordon Product Label Images

Crataegus Onopordon 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

Indications & Usage

Directions: FOR ORAL USE ONLY.

Dosage & Administration

Take 3-4 times daily. Ages 12 and older: 10 drops. Ages 2-11: 5 drops. Under age 2: Consult a doctor.

Otc - Active Ingredient

Active Ingredients: 100g contains: 50g Onopordon (Cotton thistle) 2X, 50g Primula (Cowslip) 2X, 20g Hyoscyamus (Henbane) 3X; Crataegus (Hawthorn) 3X, Cactus (Queen of the night) 4X, Cor (Bovine heart) 6X, Aurum met. (Metallic gold) 15X

Inactive Ingredient

Inactive Ingredients: Distilled water, Propolis

Otc - Purpose

Use: Temporary relief of headache.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN.

Warnings

Warnings: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Do not use if allergic to any ingredient. Consult a doctor before use for serious conditions or if conditions worsen or persist. If pregnant or nursing, consult a doctor before use. Do not use if safety seal is broken or missing.REFRIGERATE AFTER OPENING.

BEST WHEN USED WITHIN 30 DAYS OF OPENING.

Otc - Questions

Questions? Call 866.642.2858


Made with care by Uriel, East Troy, WI 53120


www.urielpharmacy.com

* Please review the disclaimer below.