NDC 70000-0024 Leader Castor Oil

Castor Oil

NDC Product Code 70000-0024

NDC Product Information

Leader Castor Oil with NDC 70000-0024 is a a human over the counter drug product labeled by Cardinal Health. The generic name of Leader Castor Oil is castor oil. The product's dosage form is oil and is administered via oral form.

Labeler Name: Cardinal Health

Dosage Form: Oil - An unctuous, combustible substance which is liquid, or easily liquefiable, on warming, and is soluble in ether but insoluble in water. Such substances, depending on their origin, are classified as animal, mineral, or vegetable oils.

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.

Leader Castor Oil 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.

  • CASTOR OIL 1 g/mL

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: Cardinal Health
Labeler Code: 70000
FDA Application Number: part334 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 03-12-2019 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.

Leader Castor Oil Product Label Images

Leader Castor Oil 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

Active Ingredient

Castor oil USP 100%

Purpose

Stimulant Laxative

Use

For relief of occasional constipation (irregularity).  Generally produces bowel movement in 6 to 12 hours.

Warnings

For this product

Do Not Use

For a period longer than 1 week

Ask A Doctor Before Use If You Have

  • Abdominal pain, nausea, or vomitingnoticed a sudden change in bowel habits that persists over a period of 2 weeks

Ask A Doctor Or Pharmacist Before Use If You Are

Taking any other drug.  Take this product 2 or more hours before or after other drugs.  Laxatives may affect how other drugs work.

Stop Use And Ask A Doctor

If you have rectal bleeding or failure to have a bowel movement after use.  These could be signs of a serious condition.

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 - 1 to a maximum of 4 tablespoons (15 to 60 mL) in a single daily dosechildren 2 to under 12 years of age - 1 to a maximum of 3 teaspoons (5 to 15 mL) in a single daily dosechildren under 2 years of age - do not use, consult a doctor

Other Information

Keep tightly closed, away from excessive heat.

Adverse Reactions

Dist. by CAH, Dublin, OH 430172019  Cardinal HealthCIN 5516034

* Please review the disclaimer below.

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