NDC 48951-8203 Spongia Ovi

Spongia Ovi

NDC Product Code 48951-8203

NDC Product Information

Spongia Ovi with NDC 48951-8203 is a a human over the counter drug product labeled by Uriel Pharmacy Inc.. The generic name of Spongia Ovi is spongia ovi. The product's dosage form is pellet and is administered via oral form.

Labeler Name: Uriel Pharmacy Inc.

Dosage Form: Pellet - A small sterile solid mass consisting of a highly purified drug (with or without excipients) made by the formation of granules, or by compression and molding.

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.

Spongia Ovi 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.

  • SPONGIA OFFICINALIS SKELETON, ROASTED 1 [hp_X]/1
  • CHELIDONIUM MAJUS 3 [hp_X]/1
  • COLCHICUM AUTUMNALE WHOLE 3 [hp_X]/1
  • CALCIUM CARBONATE 6 [hp_X]/1
  • SUGARCANE 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.

  • SUCROSE (UNII: C151H8M554)

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: 12-31-2019 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.

Spongia Ovi Product Label Images

Spongia Ovi 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

Dissolve pellets under the tongue 3-4 times daily. Ages 12 and older: 10 pellets. Ages 2-11: 5 pellets. Under age 2: Consult a doctor.

Otc - Active Ingredient

Active Ingredients: Spongia tosta (Roasted sea sponge) 1X, Chelidonium (Greater celandine) 3X, Colchicum (Meadow saffron) 3X, Calc carb. e testa ovi (Calcium carbonate from eggshells) 6X, Saccharum Sacchari (Cane sugar) 6X

Inactive Ingredient

Inactive Ingredient: Organic sucrose

Otc - Purpose

Use: Temporary relief of headache.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN.

Warnings

Warnings: Contains sugar. Diabetics and persons intolerant of sucrose (sugar): Consult a doctor before use. 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.

Otc - Questions

Questions? Call 866.642.2858 Uriel, East Troy, WI 53120 www.urielpharmacy.com

* Please review the disclaimer below.

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