NDC 69842-523 Cvs Health Stool Softener

Docusate Sodium

NDC Product Code 69842-523

NDC Code: 69842-523

Proprietary Name: Cvs Health Stool Softener 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.

Product Characteristics

Color(s):
RED (C48326)
Shape: OVAL (C48345)
Size(s):
10 MM
Imprint(s):
S10
Score: 1

NDC Code Structure

  • 69842 - Cvs Pharmacy
    • 69842-523 - Cvs Health Stool Softener

NDC 69842-523-01

Package Description: 1 BOTTLE in 1 CARTON > 100 CAPSULE in 1 BOTTLE

NDC Product Information

Cvs Health Stool Softener with NDC 69842-523 is a a human over the counter drug product labeled by Cvs Pharmacy. The generic name of Cvs Health Stool Softener is docusate sodium. The product's dosage form is capsule and is administered via oral form.

Labeler Name: Cvs Pharmacy

Dosage Form: Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.

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.

Cvs Health Stool Softener 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 50 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.

  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • POVIDONE K30 (UNII: U725QWY32X)
  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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: Cvs Pharmacy
Labeler Code: 69842
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: 06-05-2019 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Cvs Health Stool Softener Product Label Images

Cvs Health Stool Softener 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

Other

Drug Facts

Active Ingredient(In Each Softgel)

Docusate sodium 50 mg

Purpose

Stool softener

Uses

■ relieves occasional constipation (irregularity)


■ generally produces bowel movement in 12 to 72 hours

Warnings

Do not use■ if you are presently taking mineral oil, unless told to do


so by a doctor

Otc - Ask Doctor/Pharmacist

Ask a doctor before use if you have■ stomach pain ■ nausea ■ vomiting


■ noticed a sudden change in bowel habits that lasts over


2 weeks

Otc - Do Not Use

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 stool softener laxative for more than


1 week

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. 1-800-222-1222

Directions

Take only by mouth. Doses may be taken as a single daily


dose or in divided doses.


 adults and children 12 years


and over


 take 1 to 6 softgels


daily


 children 2 to under 12 years


of age


 take 1 to 3 softgels


daily


 children under 2 years ask a doctor

Other Information




each softgel contains: sodium 3 mg VERY LOW


SODIUM


■ store at 25°C (77°F); excursions permitted between


15°-30°C (59°-86°F). Keep tightly closed.

Inactive Ingredients

FD&C Red No. 40, gelatin, glycerin, polyethylene


glycol-400, povidone, propylene glycol, purified water,


sorbitol solution, titanium dioxide

Otc - Questions

Questions or comments? 1-888-333-9792

* Please review the disclaimer below.

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