NDC 0597-0151 Dulcoease Pink

Docusate Sodium

NDC Product Code 0597-0151

NDC CODE: 0597-0151

Proprietary Name: Dulcoease Pink 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: Docusate Sodium 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.

  • This medication is used to treat occasional constipation. Some medications and conditions can make constipation more likely. Stool softeners such as docusate are often the first method used for preventing and treating this type of constipation. Docusate is often used when straining to have a bowel movement should be avoided (e.g., after a heart attack or surgery). Docusate is a stool softener. It works by increasing the amount of water the stool absorbs in the gut, making the stool softer and easier to pass.

Product Characteristics

Color(s):
RED (C48326 - RED ON ONE SIDE)
WHITE (C48325 - WHITE ON THE OTHER)
Shape: OVAL (C48345)
Size(s):
13 MM
Imprint(s):
L486
Score: 1

NDC Code Structure

NDC 0597-0151-23

Package Description: 1 BOTTLE in 1 CARTON > 25 CAPSULE, LIQUID FILLED in 1 BOTTLE

NDC 0597-0151-30

Package Description: 1 BOTTLE in 1 CARTON > 30 CAPSULE, LIQUID FILLED in 1 BOTTLE

NDC 0597-0151-64

Package Description: 1 BOTTLE in 1 CARTON > 38 CAPSULE, LIQUID FILLED in 1 BOTTLE

NDC Product Information

Dulcoease Pink with NDC 0597-0151 is a a human over the counter drug product labeled by Boehringer Ingelheim Pharmaceuticals, Inc.. The generic name of Dulcoease Pink is docusate sodium. The product's dosage form is capsule, liquid filled and is administered via oral form.

Labeler Name: Boehringer Ingelheim Pharmaceuticals, Inc.

Dosage Form: Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.

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.

Dulcoease Pink 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.

  • DOCUSATE SODIUM 100 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.

  • D&C RED NO. 33 (UNII: 9DBA0SBB0L)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)
  • SORBITAN (UNII: 6O92ICV9RU)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • MANNITOL (UNII: 3OWL53L36A)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)

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: Boehringer Ingelheim Pharmaceuticals, Inc.
Labeler Code: 0597
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: 02-01-2013 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 11-30-2021 What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

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".

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Information for Patients

Stool Softeners

Stool Softeners is

Why is stool softeners medication prescribed?
Stool softeners are used on a short-term basis to relieve constipation by people who should avoid straining during bowel movements because of heart conditions, hemorrhoid...
[Read More]

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Dulcoease Pink 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

Otc - Active Ingredient

Drug FactsActive ingredient (in each capsule)PurposeDocusate sodium (USP) 100 mgStool softener laxative

Otc - Purpose

  • Usefor temporary relief of occasional constipation and irregularitythis product generally produces bowel movement in 12 to
  • 72 hours

Warnings

Warnings

Otc - Ask Doctor/Pharmacist

  • Ask a doctor before use if you havestomach pain, nausea or vomitinga sudden change in bowel habits that lasts more than 2 weeksAsk a doctor or pharmacist
  • Before use if you are presently taking mineral oil

Otc - Stop Use

  • Stop use and ask
  • A doctor ifyou 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 - Keep Out Of Reach Of Children

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.

Dosage Forms & Strengths

Directions take with a glass of wateradults and children 12 years
of age and over1 to 3 capsules daily. This
dose may be taken as a single daily dose or in divided doses.children 2 to under 12 years
of age1 capsule dailychildren under 2 years of age ask a doctor

Otc - When Using

  • Other informationeach capsule contains: sodium 6 mgstore at 20–25°C (68-77°F)protect from excessive humiditydo not use this product if the safety seal under the cap
  • Is torn or missing

Inactive Ingredient

Inactive ingredients black iron oxide, D&C
Red #33, FD&C Blue #1, FD&C Red #40, FD&C Yellow #6, gelatin,
glycerin, high polychains, hypromellose, isopropyl alcohol, mannitol,
polyethylene glycol 400, propylene glycol, sorbitan, sorbitol, titanium
dioxide, water

* Please review the disclaimer below.