NDC 41167-0400 Dulcolax Stimulant Laxative

Bisacodyl

NDC Product Code 41167-0400

NDC Code: 41167-0400

Proprietary Name: Dulcolax 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):
5 MM
Imprint(s):
DU
Score: 1

NDC Code Structure

  • 41167 - Chattem, Inc.
    • 41167-0400 - Dulcolax Stimulant Laxative

NDC 41167-0400-1

Package Description: 1 BLISTER PACK in 1 CARTON > 10 TABLET, COATED in 1 BLISTER PACK

NDC 41167-0400-2

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

NDC 41167-0400-3

Package Description: 2 BLISTER PACK in 1 CARTON > 25 TABLET, COATED in 1 BLISTER PACK

NDC 41167-0400-4

Package Description: 4 BLISTER PACK in 1 CARTON > 25 TABLET, COATED in 1 BLISTER PACK

NDC 41167-0400-5

Package Description: 1 BLISTER PACK in 1 CARTON > 8 TABLET, COATED in 1 BLISTER PACK

NDC 41167-0400-6

Package Description: 8 BLISTER PACK in 1 CARTON > 25 TABLET, COATED in 1 BLISTER PACK

NDC 41167-0400-8

Package Description: 3 BLISTER PACK in 1 CARTON > 10 TABLET, COATED in 1 BLISTER PACK

NDC Product Information

Dulcolax Stimulant Laxative with NDC 41167-0400 is a a human over the counter drug product labeled by Chattem, Inc.. The generic name of Dulcolax Stimulant Laxative is bisacodyl. The product's dosage form is tablet, coated and is administered via oral form.

Labeler Name: Chattem, Inc.

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.

Dulcolax 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 CARBONATE (UNII: H0G9379FGK)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • POLYDEXTROSE (UNII: VH2XOU12IE)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)
  • POVIDONE (UNII: FZ989GH94E)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • SHELLAC (UNII: 46N107B71O)
  • 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: Chattem, Inc.
Labeler Code: 41167
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: 04-14-2019 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

Bismuth Subsalicylate

Bismuth Subsalicylate is pronounced as (biz muth) (sub sa lis' i late)

Why is bismuth subsalicylate medication prescribed?
Bismuth subsalicylate is used to treat diarrhea, heartburn, and upset stomach in adults and children 12 years of age and older. Bismuth subsalicylate is in a class of med...
[Read More]

* Please review the disclaimer below.

Dulcolax 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 relief of occasional constipation and irregularity● this product generally produces 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 ● noticed a sudden change in bowel habits that lasts more than 2 weeks

When Using This Product

● it may cause stomach discomfort, faintness and cramps ● do not chew or crush tablet(s)● do not use within 1 hour after taking an antacid or milk

Stop Use And Ask A Doctor If

● you have rectal bleeding or fail to have a 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 Pregnant 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.

Directions

Take with a glass of wateradults and children 12 years of age and over
     

     

     
1 to 3 tablets in a single daily dosechildren 6 to under 12 years of age
     

     

     

     
1 tablet in a single daily dosechildren under 6 years of age
     

     

     

     

     
ask a doctor

Other Information

● contains FD&C Yellow No. 6 ● do not use if individual blister unit is open or torn● store at 20°-25°C (68°-77°F)  ● protect from excessive humidity

Inactive Ingredients

Acacia senegal gum, ammonium hydroxide, calcium carbonate, carnauba wax, colloidal anhydrous silica, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, iron oxides, lactose, magnesium stearate, methylparaben, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparaben, shellac, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate

Questions?

Call 1-866-844-2798 or visit www.Dulcolax.comKeep carton as it contains important product information.

* Please review the disclaimer below.

Previous Code
41167-0342
Next Code
41167-0404