NDC 52327-011 Extra Strength Stool Softener Laxative

NDC Product Code 52327-011

NDC CODE: 52327-011

Proprietary Name: Extra Strength Stool Softener 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: 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: OVAL (C48345)
Size(s):
20 MM
Imprint(s):
P20
Score: 1

NDC Code Structure

  • 52327 - Aidapak Services, Llc
    • 52327-011 - Extra Strength Stool Softener Laxative

NDC 52327-011-11

Package Description: 100 BLISTER PACK in 1 BLISTER PACK > 1 mg in 1 BLISTER PACK (52327-011-10)

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Extra Strength Stool Softener Laxative with NDC 52327-011 is a product labeled by Aidapak Services, Llc. The generic name of Extra Strength Stool Softener Laxative is . The product's dosage form is and is administered via form.

Labeler Name: Aidapak Services, Llc

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.

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

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Aidapak Services, Llc
Labeler Code: 52327
Start Marketing Date: 10-20-2014 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: 12-31-2017 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: I - INACTIVATED, the listing data was inactivated by the FDA. 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.

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]

* Please review the disclaimer below.

Extra Strength Stool Softener 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

Otc - Active Ingredient

Active Ingredient (in each softgel)Docusate Sodium 250 mg

Otc - Purpose

PurposeStool Softener

Indications & Usage

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.

Warnings

Do not use•if you are currently taking mineral oil, unless directed by a doctor•when abdominal pain, nausea, orvomiting are present•for more than 1 week, unless directed by a doctor.

Otc - Ask Doctor

Ask a doctor before use if:•you notice a sudden change in bowel habits that persists over a period of 2 weeks.Stop use and ask a doctor if:•you have rectal bleeding•you fail to have a bowel movement after use. These could be signs of a serious condition.

Otc - 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 Poison Control Center right away.

Information For Patients

Directions:Adults and children 12 years of age and over:take 1 softgel daily or as directed by a doctor.Children under 12 years of age: take as directed by doctor.Other Information:each softgel contains: sodium 15 mg.Store between 15-30 C (59-86 F)

Inactive Ingredient

Edible white ink, FD&C red 40, FD&C yellow 6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water and sorbitol special.

* Please review the disclaimer below.