NDC 17856-0398 Stool Softener Liquid

Docusate Sodium

NDC Product Code 17856-0398

NDC CODE: 17856-0398

Proprietary Name: Stool Softener Liquid 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):
PINK (C48328)
Flavor(s):
RASPBERRY (C73413)

NDC Code Structure

NDC 17856-0398-1

Package Description: 50 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE > 25 mL in 1 CUP, UNIT-DOSE

NDC 17856-0398-2

Package Description: 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE > 10 mL in 1 CUP, UNIT-DOSE

NDC Product Information

Stool Softener Liquid with NDC 17856-0398 is a a human over the counter drug product labeled by Atlantic Biologicals Corp.. The generic name of Stool Softener Liquid is docusate sodium. The product's dosage form is liquid and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1245686.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Stool Softener Liquid 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.


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.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • D&C RED NO. 33 (UNII: 9DBA0SBB0L)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • WATER (UNII: 059QF0KO0R)
  • POLOXAMER 407 (UNII: TUF2IVW3M2)
  • SUCROSE (UNII: C151H8M554)
  • SORBITOL (UNII: 506T60A25R)

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: Atlantic Biologicals Corp.
Labeler Code: 17856
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: 09-01-2017 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: 12-31-2022 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.

Stool Softener Liquid Product Label Images

Stool Softener Liquid 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 5 Ml Teaspoonful)

Docusate Sodium 50 mg

Purpose

Stool Softener Laxative

Uses

  • Relieves occasional constipation (irregularity)generally produces bowel movement in 12 to 72 hours

Warnings

  • Do not use for more than one week unless directed by a doctor
  • Ask a doctor before use if youhave abdominal pain, nausea, or vomitingare taking mineral oilhave noticed a sudden change in bowel habits that lasts more than 14 daysStop use and ask a doctor ifyou have rectal bleeding or failure to have a bowel movement within 3 days. These could be signs of a serious condition.a skin rash occursyou experience throat irritation

Otc - Pregnancy Or Breast Feeding

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

  • Follow dosing directions below or take as directed by doctormust be given in a 6 to 8 oz glass of milk or fruit juice to prevent throat irritationmay be taken as a single daily dose or in divided dosestake maximum daily dose until first bowel movement, then reduce dose according to individual responseshake well before usingAdults and children 12 years and over
  • 1 to 4 teaspoonfuls (5 to 20 mL)
  • Children under 12 years of age
  • Ask a doctor

Other Information

  • Each teaspoonful contains: sodium 15 mg
  • Store at room temperature 15°- 30° C (59°-86° F)protect from excessive heatKeep tightly closed

Inactive Ingredients

Citric acid, D&C Red #33, flavor, parabens, poloxamer, polyethylene glycol, sodium citrate, sorbitol, sucrose, and water.DISTRIBUTED BY:ATLANTIC BIOLOGICALS CORP.20101 N.E 16TH PLACE MIAMI, FL 33179

Package Label

NDC 17856-0398-1Compare to Colace® Liquid active ingredient *GOOD NEIGHBOR PHARMACYSTOOL SOFTENER LIQUID Docusate Sodium Relieves Constipation 250mg/25 mL 50 cups per caseNDC 17856-0398-2Compare to Colace® Liquid active ingredient *GOOD NEIGHBOR PHARMACYSTOOLSOFTENERLIQUIDDocusate SodiumRelieves Constipation100mg/10 mL72 cups per case

* Please review the disclaimer below.