NDC 11673-151 Womens Gentle Laxative

Bisacodyl

NDC Product Code 11673-151

NDC Code: 11673-151

Proprietary Name: Womens 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 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.

Product Characteristics

Color(s):
PINK (C48328)
Shape: ROUND (C48348)
Size(s):
5 MM
Imprint(s):
TCL
Score: 1

NDC Code Structure

  • 11673 - Target Corporation
    • 11673-151 - Womens Gentle Laxative

NDC 11673-151-52

Package Description: 25 TABLET in 1 CARTON

NDC Product Information

Womens Gentle Laxative with NDC 11673-151 is a a human over the counter drug product labeled by Target Corporation. The generic name of Womens Gentle Laxative is bisacodyl. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Target Corporation

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

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.

Womens 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 5 mg/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.

  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • POVIDONE (UNII: FZ989GH94E)
  • SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
  • POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)
  • RAW SUGAR (UNII: 8M707QY5GH)
  • ACACIA (UNII: 5C5403N26O)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • D&C RED NO. 27 (UNII: 2LRS185U6K)
  • FOOD YELLOW 3 FREE ACID (UNII: G2B7JWK1GG)
  • GELATIN (UNII: 2G86QN327L)
  • FERROUS OXIDE (UNII: G7036X8B5H)
  • CALCIUM CATION (UNII: 2M83C4R6ZB)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • SHELLAC (UNII: 46N107B71O)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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: Target Corporation
Labeler Code: 11673
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: 04-01-2019 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.

Information for Patients

Bisacodyl

Bisacodyl is pronounced as (bis ak' oh dil)

Why is bisacodyl medication prescribed?
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 class ...
[Read More]

* Please review the disclaimer below.

Womens Gentle Laxative Product Label Images

Womens 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 tablet: Bisacodyl 5mg

Inactive Ingredients

Acacia, Anhydrous Calcium Sulfate, Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Corn Starch, D&C Red #27 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, Gelatin, Iron Oxide, Iron Oxide Black, Iron Oxide Yellow (Iron Oxide Ochre), Magnesium Stearate,Microcrystalline Cellulose, Polyethylene Glycol (PEG) 400, Polyvinyl Acetate Phthalate, Povidone,Shellac, Sodium Starch Glycolate, Stearic Acid, Sugar, Talc, Titanium Dioxide

Otc - Purpose

Stimulant Laxative

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.

Indications & Usage

Temporarily relieves occasional constipation and irregularity

Warnings

Warning: Do not use if you cannot swallow without chewing.Ask a doctor before use if you have: stomach pain, nausea or vomiting; A sudden change in bowel habits that lasts more than two weeks.When using this product: Do not chew or crush tablet(s); Do not use within 1 hour after taking an antacid or milk; Do not use this product if you have stomack discomfort, faintness or cramps.

Dosage & Administration

Adults and children 12 years and over: take 1 to 3 tablets (usually 2A) daily, or as directed by a doctor

children 6 to under 12 years: take 1 tablet daily, or as directed by a doctor

children under 6 year ask a doctor

* Please review the disclaimer below.

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