NDC 0363-0466 Walgreens Gentle Laxative

Bisacodyl Suppository

NDC Product Code 0363-0466

NDC CODE: 0363-0466

Proprietary Name: Walgreens Gentle 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: Bisacodyl Suppository 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.

  • Bisacodyl is used to treat constipation. It may also be used to clean out the intestines before a bowel examination/surgery. Bisacodyl is known as a stimulant laxative. It works by increasing the movement of the intestines, helping the stool to come out.
  • Bisacodyl is used to treat constipation. It may also be used to clean out the intestines before a bowel examination/surgery. Bisacodyl is known as a stimulant laxative. It works by increasing the movement of the intestines, helping the stool to come out.
  • Bisacodyl is used to treat constipation. It may also be used to clean out the intestines before a bowel examination/surgery. Bisacodyl is known as a stimulant laxative. It works by increasing the movement of the intestines, helping the stool to come out.

NDC Code Structure

NDC 0363-0466-04

Package Description: 2 BLISTER PACK in 1 PACKAGE > 40 mg in 1 BLISTER PACK

NDC 0363-0466-09

Package Description: 2 BLISTER PACK in 1 PACKAGE > 40 mg in 1 BLISTER PACK (0363-0466-08)

NDC 0363-0466-31

Package Description: 5 CARTRIDGE in 1 PACKAGE > 60 mg in 1 CARTRIDGE (0363-0466-30)

NDC Product Information

Walgreens Gentle Laxative with NDC 0363-0466 is a a human over the counter drug product labeled by Walgreens. The generic name of Walgreens Gentle Laxative is bisacodyl suppository. The product's dosage form is suppository and is administered via rectal form.

Labeler Name: Walgreens

Dosage Form: Suppository - A solid body of various weights and shapes, adapted for introduction into the rectal orifice of the human body; they usually melt, soften, or dissolve at body temperature.

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.

Walgreens Gentle 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.

  • BISACODYL 10 mg/2000mg
  • BISACODYL 10 mg/2000mg
  • BISACODYL 10 mg/2000mg

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.

  • PALM KERNEL OIL (UNII: B0S90M0233)

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.
  • Rectal - Administration to the rectum.
  • 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: Walgreens
Labeler Code: 0363
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: 09-18-2014 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 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.

Information for Patients

Bisacodyl Rectal

Bisacodyl Rectal is pronounced as (bis ak' oh dil)

Why is bisacodyl rectal medication prescribed?
Rectal bisacodyl is used on a short-term basis to treat constipation. It also is used to empty the bowels before surgery and certain medical procedures. Bisacodyl is in a...
[Read More]

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Walgreens Gentle Laxative Product Label Images

Walgreens Gentle 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

Active Ingredient (In Each Suppository)

Active Ingredient                                              Purpose(in each Suppository)Bisacodyl 10 mg.................................Stimulant Laxative

Uses

-for relief of occasional constipation-this product generally produces bowel movement in 1/4 to 1 hour

Warnings

For rectal use only.

Do Not Use

Do not use -when abdominal pain, nausea, or vomiting are present-for a period of longer than 1 week

Ask A Doctor

Ask a doctor before use if you have noticed a sudden change in bowel habits that lasts over a period of 2 weeks

When Using This Product

When using this product it may cause abdominal discomfort, faintness, rectal burning and mild cramps

Stop Use And Ask A Doctor If

Stop use and ask a doctor if -you have rectal bleeding -you fail to have a bowel movement after using this product.  This may indicate a serious condition

If Pregnant Or Breast-Feeding

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

Keep Out Of Reach Of Children

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Directions

-detach one suppository from the strip-remove wrapper before inserting into the rectumadults and children 12 years of age and older         1 suppository once daily            children 6 to under 12 years                                     1/2 suppository once dailychildren under 6 years                                              do not use

-detach one suppository from the strip-remove wrapper before inserting into the rectumadults and children 12 years of age and older            1 suppository once dailychildren 6 to under 12 years                                       1/2 suppository once dailychildren under 6 years                                                do not use

Other Information

Other information-Store at room temperature.  Do not exceed 30oC (86oF)-Lot No. & Exp. Date: see wrapper or box

Inactive Ingredient

Inactive ingredient  hydrogenated vegetable oil

* Please review the disclaimer below.