NDC 71335-1531 Stimulant Laxative Enteric Coated

Bisacodyl

NDC Product Code 71335-1531

NDC CODE: 71335-1531

Proprietary Name: Stimulant Laxative Enteric Coated 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.

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.

Product Characteristics

Color(s):
ORANGE (C48331)
Shape: ROUND (C48348)
Size(s):
6 MM
Imprint(s):
5
Score: 1

NDC Code Structure

NDC 71335-1531-1

Package Description: 30 TABLET in 1 BOTTLE

NDC 71335-1531-2

Package Description: 2 TABLET in 1 BOTTLE

NDC 71335-1531-3

Package Description: 3 TABLET in 1 BOTTLE

NDC 71335-1531-4

Package Description: 4 TABLET in 1 BOTTLE

NDC 71335-1531-5

Package Description: 10 TABLET in 1 BOTTLE

NDC 71335-1531-6

Package Description: 90 TABLET in 1 BOTTLE

NDC 71335-1531-7

Package Description: 8 TABLET in 1 BOTTLE

NDC 71335-1531-8

Package Description: 100 TABLET in 1 BOTTLE

NDC 71335-1531-9

Package Description: 20 TABLET in 1 BOTTLE

NDC Product Information

Stimulant Laxative Enteric Coated with NDC 71335-1531 is a a human over the counter drug product labeled by Bryant Ranch Prepack. The generic name of Stimulant Laxative Enteric Coated is bisacodyl. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Bryant Ranch Prepack

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.

Stimulant Laxative Enteric Coated 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.

  • ACACIA (UNII: 5C5403N26O)
  • AMMONIA (UNII: 5138Q19F1X)
  • CALCIUM CARBONATE (UNII: H0G9379FGK)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • POLYDEXTROSE (UNII: VH2XOU12IE)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
  • SHELLAC (UNII: 46N107B71O)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SODIUM ALGINATE (UNII: C269C4G2ZQ)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • SUCROSE (UNII: C151H8M554)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • TRIACETIN (UNII: XHX3C3X673)
  • TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

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: Bryant Ranch Prepack
Labeler Code: 71335
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: 01-01-2000 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.

Stimulant Laxative Enteric Coated Product Label Images

Stimulant Laxative Enteric Coated 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 5 mg

Purpose

Stimulant Laxative

Uses

  • Relieves occasional constipation and irregularitygenerally produces a bowel movement in 6 to 12 hours

Warnings

Do not use
• for more than one week unless directed by a doctor




• if you cannot swallow without chewing




• within 1 hour after taking an antacid or milk



Ask a doctor before use if you have
• abdominal pain




• nausea




• vomiting




• a sudden change in bowel habits that lasts longer than 2 weeks



When using this product • abdominal discomfort, faintness, or cramps may occur



Stop use and ask a doctor
• if you have no bowel movement within 12 hours




• if you have rectal bleeding




• these could be signs of a serious condition



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.

Directions

• do not take more than directed





• swallow whole, do not chew or crush





• take recommended dose in a single daily dose





• take with water





• adults and children 12 years and older: take 1-3 (usually 2) tablets daily





• children 12 and under: ask a doctor

Other Information

• store at room temperature





• avoid excessive humidity





• Tamper Evident: Do not use if imprinted seal under cap is missing or broken





• package not child resistant





• for institutional use only

Inactive Ingredients

Acacia, Ammonium Hydroxide, Calcium Carbonate, Corn Starch, D and C Yellow NO. 10 Lake, FD and C Yellow NO. 6 Lake, Hypromellose, Iron Oxide Black, Lactose, Magnesium Stearate, Methylparaben, PEG, Polydextrose, Polyvinyl Acetate Phthalate, Propylparaben, Propylene Glycol, Povidone, Shellac, Simethicone, Silica, Sodium Alginate, Sodium Benzoate, Sodium Bicarbonate, Stearic Acid, Sucrose, Talc, Titanium Dioxide, Triacetin, Triethyl Citrate, Wax. May also contain: Calcium Sulfate, Gelatin, Sodium Starch Glycolate.

How Supplied

Product: 71335-1531NDC: 71335-1531-1 30 TABLET in a BOTTLENDC: 71335-1531-2 2 TABLET in a BOTTLENDC: 71335-1531-3 3 TABLET in a BOTTLENDC: 71335-1531-4 4 TABLET in a BOTTLENDC: 71335-1531-5 10 TABLET in a BOTTLENDC: 71335-1531-6 90 TABLET in a BOTTLENDC: 71335-1531-7 8 TABLET in a BOTTLENDC: 71335-1531-8 100 TABLET in a BOTTLENDC: 71335-1531-9 20 TABLET in a BOTTLE

* Please review the disclaimer below.