NDC 48951-1298 Aesculinum Comp. Special Order

Aesculinum Comp. Special Order

NDC Product Code 48951-1298

NDC 48951-1298-1

Package Description: 1 BOTTLE, DROPPER in 1 BAG > 7 mL in 1 BOTTLE, DROPPER

NDC Product Information

Aesculinum Comp. Special Order with NDC 48951-1298 is a a human over the counter drug product labeled by Uriel Pharmacy Inc.. The generic name of Aesculinum Comp. Special Order is aesculinum comp. special order. 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.

Aesculinum Comp. Special Order 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.

  • BOS TAURUS PLACENTA 8 [hp_X]/mL
  • BOS TAURUS NERVE 12 [hp_X]/mL
  • BOS TAURUS DIENCEPHALON 12 [hp_X]/mL
  • BOS TAURUS EYE 10 [hp_X]/mL
  • ESCULIN 6 [hp_X]/mL
  • BOS TAURUS FRONTAL LOBE 12 [hp_X]/mL
  • BOS TAURUS BRAIN 12 [hp_X]/mL
  • SUS SCROFA TEMPORAL LOBE 12 [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)
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)

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: 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: 12-31-2020 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.

Aesculinum Comp. Special Order 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.

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: Aesculinum (Aesculin) 6X, Placenta (Bovine placenta) 8X, Lens cristallina (Bovine crystalline lens of the eye) 10X, Corpus vitreum (Bovine vitreous body of the eye) 12X, Diencephalon (Bovine Diencephalon) 12X, Lobus frontalis (Bovine frontal lobe of the brain) 12X, Lobus occipitalis (Bovine occipital lobe of the brain) 12X, Lobus parietalis (Bovine parietal lobe of the brain) 12X, Lobus temporalis (Bovine temporal lobe of the brain) 12X, Nervus opticus (Bovine second cranial nerve) 12X, Retina et chor. (Bovine retina and choroid) 12X

Inactive Ingredient

Inactive Ingredients: Water, Salt, Sodium bicarbonate

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. USE WITHIN 30 DAYS OF OPENING.

Otc - Questions

Questions? Call 866.642.2858

Made by Uriel, East Troy, WI 53120

www.urielpharmacy.com

* Please review the disclaimer below.