NDC 68210-4106 Bisacodyl

Bisacodyl

NDC Product Code 68210-4106

NDC CODE: 68210-4106

Proprietary Name: Bisacodyl 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):
5 MM
Imprint(s):
TCL003
Score: 1

NDC Code Structure

NDC 68210-4106-1

Package Description: 75 TABLET in 1 PACKAGE

NDC 68210-4106-2

Package Description: 1 BOTTLE in 1 CARTON > 30 TABLET in 1 BOTTLE

NDC Product Information

Bisacodyl with NDC 68210-4106 is a a human over the counter drug product labeled by Spirit Pharmaceuticals Llc. The generic name of Bisacodyl is bisacodyl. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Spirit Pharmaceuticals Llc

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.

Bisacodyl 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)
  • CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)
  • ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • GELATIN (UNII: 2G86QN327L)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)
  • POVIDONE K30 (UNII: U725QWY32X)
  • SHELLAC (UNII: 46N107B71O)
  • SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • SUCROSE (UNII: C151H8M554)

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.
  • 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: Spirit Pharmaceuticals Llc
Labeler Code: 68210
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: 07-06-2020 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.

Bisacodyl 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 (USP) 5 mg

Purpose

Stimulant laxative

Uses

  • For temporary relief of occasional constipation and irregularity this product generally produces bowel movement in 6 to 12 hours

Warnings

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 2








weeks

When Using This Product

■ do not chew or crush tablet(s)








■ it may cause stomach discomfort, faintness and cramps








■ do not use within 1 hour after taking an antacid or milk

Stop Use And Ask A Doctor If

■ you have rectal bleeding or no bowel movement after








using this product. These could be signs of a serious








condition.








■ you need to use a laxative for more than 1 week

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Dosage & Administration

  • Directionstake with a glass of water adults and children 12 years and over 1 to 3 tablets in a single daily dose children 6 to under 12 years of age 1 tablet in a single daily dose children under 6 years of age ask a doctor

Other Safety Information

Other information■








each tablet contains: magnesium 5 mg








■ store at 20-25°C (68-77°F)








■ protect from excessive humidity

Inactive Ingredients

Acacia, anhydrous calcium sulfate, anhydrous lactose,








carnauba wax, colloidal silicon dioxide, corn starch, D&C








Yellow #10 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 - Questions

Questions or comments? 1-888-333-9792

* Please review the disclaimer below.