NDC 41250-258 Stool Softener Extra Strength

Docusate Sodium

NDC Product Code 41250-258

NDC Code: 41250-258

Proprietary Name: Stool Softener Extra Strength Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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: CAPSULE (C48336)
Size(s):
20 MM
Imprint(s):
P20;SCU1
Score: 1

Code Structure
  • 41250 - Meijer, Inc.
    • 41250-258 - Stool Softener

NDC 41250-258-10

Package Description: 100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC

NDC Product Information

Stool Softener Extra Strength with NDC 41250-258 is a a human over the counter drug product labeled by Meijer, Inc.. The generic name of Stool Softener Extra Strength is docusate sodium. The product's dosage form is capsule, liquid filled and is administered via oral form.

Labeler Name: Meijer, 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 Additional informationCallout TooltipWhat 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 Extra Strength Active Ingredient(s)

Additional informationCallout TooltipWhat 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 250 mg/1

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)
  • SORBITAN (UNII: 6O92ICV9RU)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Meijer, Inc.
Labeler Code: 41250
FDA Application Number: part334 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 01-31-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Stool Softener Extra Strength Product Label Images

Stool Softener Extra Strength 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 Softgel)

Docusate sodium 250 mg

Purpose

Stool softener laxative

Uses

  • For the prevention of dry, hard stools
  • For relief of occasional constipation
  • This product generally produces a bowel movement within 12 to 72 hours

Do Not Use

If you are presently taking mineral oil, unless directed by a doctor.

Ask A Doctor Before Use If You Have

  • Stomach painnauseavomitingnoticed a sudden change in bowel habits that last over 2 weeks

Stop Use And Ask A Doctor If

  • You have rectal bleeding or fail to have a bowel movement after use of a laxative. 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

  • Adults and children 12 years of age and over: take 1 softgel daily or as directed by a doctorchildren under 12 years of age: ask a doctor

​​Other Information

  • Each softgel contains: sodium 15 mgstore at 20º-25ºC(68º-77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

Inactive Ingredients

Edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol*, purified water, sorbitol special*may contain this ingredient

Product Label

MEIJER Extra Strength Stool Softener

* Please review the disclaimer below.

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