NDC 63868-908 Gentle Laxative Stimulant Laxative

Bisacodyl

NDC Product Code 63868-908

NDC Code: 63868-908

Proprietary Name: Gentle Laxative Stimulant 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):
ORANGE (C48331)
Shape: ROUND (C48348)
Size(s):
6 MM
Imprint(s):
RP116
Score: 1

Code Structure
  • 63868 - Quality Choice (chain Drug Marketing Association)
    • 63868-908 - Gentle Laxative

NDC 63868-908-25

Package Description: 1 BLISTER PACK in 1 CARTON > 25 TABLET, COATED in 1 BLISTER PACK

NDC Product Information

Gentle Laxative Stimulant Laxative with NDC 63868-908 is a a human over the counter drug product labeled by Quality Choice (chain Drug Marketing Association). The generic name of Gentle Laxative Stimulant Laxative is bisacodyl. The product's dosage form is tablet, coated and is administered via oral form.

Labeler Name: Quality Choice (chain Drug Marketing Association)

Dosage Form: Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.

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.


Gentle Laxative Stimulant 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.

  • 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, UNSPECIFIED (UNII: 2G86QN327L)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)
  • POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
  • SHELLAC (UNII: 46N107B71O)
  • SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • SUCROSE (UNII: C151H8M554)
  • 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: Quality Choice (chain Drug Marketing Association)
Labeler Code: 63868
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: 04-19-2019 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.

Gentle Laxative Stimulant Laxative Product Label Images

Gentle Laxative Stimulant 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, USP 5 mg

Purpose

Stimulant laxative

Use

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

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) •do not use within 1 hour after taking an antacid or milk •it may cause stomach discomfort, faintness and cramps

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

If Pregnancy Or Breast-Feeding,

Ask a health professional before use.

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

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

Other Information

  • •store at 20-25ºC (68º-77ºF) •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, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide.

Product Label

QC(CDMA) Gentle Laxative

* Please review the disclaimer below.

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