NDC 63868-638 Stool Softener Laxative

NDC Product Code 63868-638

NDC CODE: 63868-638

Proprietary Name: 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.

Product Characteristics

Color(s):
RED (C48326)
WHITE (C48325)
Shape: OVAL (C48345)
Size(s):
12 MM
Imprint(s):
PC18
Score: 1

NDC Code Structure

  • 63868 - Quality Choice (chain Drug Marketing Association)

NDC 63868-638-25

Package Description: 250 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC

This product is EXCLUDED from the official NDC directory .

NDC Product Information

Stool Softener Laxative with NDC 63868-638 is a product labeled by Quality Choice (chain Drug Marketing Association). The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1115005.

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)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SORBITAN (UNII: 6O92ICV9RU)
  • SORBITOL (UNII: 506T60A25R)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • ALCOHOL (UNII: 3K9958V90M)
  • AMMONIA (UNII: 5138Q19F1X)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
  • POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)

Product Labeler Information

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

Labeler Name: Quality Choice (chain Drug Marketing Association)
Labeler Code: 63868
Start Marketing Date: 12-30-2021 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: 12-31-2021 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: 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 Laxative Product Label Images

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

Active Ingredient (In Each Softgel)

Docusate sodium 100 mg

Purpose

Stool softener laxative

Uses

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

Do Not Use

If you are presently taking mineral oil, unless told to do so by a doctor.

Ask A Doctor Before Use If You Have

  • Stomach pain nausea vomiting a sudden change in bowel habits that lasts 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 (1-800-222-1222) right away.

Directions

  • Take only by mouth. Doses may be taken as a single daily dose or in divided doses.adults and children 12 years and overtake 1-3 softgels daily children 2 to under 12 years of age take 1 softgel daily children under 2 years ask a doctor

Other Information

  • Each softgel contains:sodium 5 mg store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)

Inactive Ingredients

Ammonium hydroxide, anhydrous citric acid, D&C red #33, ethyl alcohol, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, isopropyl alcohol, lecithin, mineral oil, n-butyl alcohol, polyethylene glycol, potassium hydroxide, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

Product Label

TopCare Stool Softener Softgels

* Please review the disclaimer below.