NDC 11822-3340 Mineral Oil

Mineral Oil

NDC Product Code 11822-3340

NDC Product Information

Mineral Oil with NDC 11822-3340 is a a human over the counter drug product labeled by Rite Aid Corporation. The generic name of Mineral Oil is mineral oil. The product's dosage form is oil and is administered via oral; topical form.

Labeler Name: Rite Aid Corporation

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.

Mineral 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.

  • MINERAL OIL 100 mg/100mL

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.

  • TOCOPHEROL (UNII: R0ZB2556P8)

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.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Rite Aid Corporation
Labeler Code: 11822
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: 05-31-2019 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.

Mineral Oil Product Label Images

Mineral 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

Mineral Oil 100%

Purpose

Lubricant laxative

Uses

  • Relieves occasional constipation (irregularity)generally produces bowel movement in 6 to 8 hours

Do Not Use

  • In children under 12 years of age, pregnant wormen, bedridden patients or aged, or if you have difficulty swallowingif you are presently taking a stool softener laxativefor 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

When Using This Product

  • Do not take with mealstake only at bedtime

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 (1-800-222-1222) right away.

Directions

  • Do not take with mealstake only at bedtimemay be taken as a single daily dose or in divided dosesadults and children 12 years of age and over1 to 3 tablespoons (15 to 45 mL)maximum 3 tablespoons (45 mL) in 24 hourschildren under 12 years, consult a doctor

Other Information

  • Keep tightly closedprotect from direct light

Inactive Ingredient

Vitamin E as stabilizer

Package Label

RITE AID Mineral Oil

* Please review the disclaimer below.

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