NDC 46122-363 Good Neighbor Pharmacy Mineral Oil Laxative

Mineral Oil

NDC Product Code 46122-363

NDC CODE: 46122-363

Proprietary Name: Good Neighbor Pharmacy Mineral Oil Laxative What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Mineral Oil What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Mineral oil is used to treat constipation. It is known as a lubricant laxative. It works by keeping water in the stool and intestines. This helps to soften the stool and also makes it easier for stool to pass through the intestines. This medication should not be used in older adults, children younger than 6 years, or in people who are bedridden.

NDC Code Structure

  • 46122 - Amerisourcebergen
    • 46122-363 - Good Neighbor Pharmacy Mineral Oil Laxative

NDC 46122-363-28

Package Description: 1 BOTTLE in 1 CARTON > 133 mL in 1 BOTTLE

NDC Product Information

Good Neighbor Pharmacy Mineral Oil Laxative with NDC 46122-363 is a a human over the counter drug product labeled by Amerisourcebergen. The generic name of Good Neighbor Pharmacy Mineral Oil Laxative is mineral oil. The product's dosage form is enema and is administered via rectal form.

Labeler Name: Amerisourcebergen

Dosage Form: Enema - A rectal preparation for therapeutic, diagnostic, or nutritive purposes.

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.

Good Neighbor Pharmacy Mineral Oil Laxative 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 118 g/118mL

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Rectal - Administration to the rectum.

Product Labeler Information

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

Labeler Name: Amerisourcebergen
Labeler Code: 46122
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: 03-15-2016 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Good Neighbor Pharmacy Mineral Oil Laxative Product Label Images

Good Neighbor Pharmacy Mineral Oil Laxative 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

Other

Drug Facts

Distributed ByAmerisourceBergen1300 Morris DriveChesterbrook, PA 19087

Active Ingredients (In Each 118 Ml Delivered Dose)

Mineral oil 100%

Purpose

Lubricant laxative

Use

  • For relief of occasional constipation

Warnings

For rectal use only

Ask A Doctor Before Use If You Have

  • Abdominal pain, nausea, or vomitingnotice a sudden change in bowel habits that persists over a period of 2 weeksalready used a laxative for more than 1 week

Stop Use And Ask A Doctor If

  • You have rectal bleeding or failure to have a bowel movement after use of a laxative because this may indicate a serious conditionyou need to us a laxative for more than one week

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

Single daily doseadults & children 12 years and over1 bottle once dailychildren 2 to under 12 years1/2 bottle once daily discard unused portionchildren under 2 yearsDO NOT USE

Other Information

  • Store at 15 to 30°C (59 to 86°F).this product generally produces a bowel movement in 1 to 5 minutes

Inactive Ingredients

None

* Please review the disclaimer below.