NDC 55154-9629 Docu Liquid

Docusate Sodium

NDC Product Code 55154-9629

NDC CODE: 55154-9629

Proprietary Name: Docu 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):
VANILLA (C73421 - NATURAL AND ARTIFICIAL FLAVOR)

NDC Code Structure

  • 55154 - Cardinal Health

NDC 55154-9629-5

Package Description: 5 CUP, UNIT-DOSE in 1 BAG > 10 mL in 1 CUP, UNIT-DOSE

NDC Product Information

Docu Liquid with NDC 55154-9629 is a a human over the counter drug product labeled by Cardinal Health. The generic name of Docu 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: 1248119.

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.

Docu 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.

  • D&C RED NO. 33 (UNII: 9DBA0SBB0L)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
  • WATER (UNII: 059QF0KO0R)
  • POLOXAMER 181 (UNII: 09Y8E6164A)

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: Cardinal Health
Labeler Code: 55154
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: 08-01-1997 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: 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.

Docu 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

Docusate Sodium 50 mg

Purpose

Stool Softener Laxative

Uses

  • •relieves occasional constipation •generally produces bowel movement in 12-72

Do Not Use

  • •if you are presently taking mineral oil •when abdominal pain, nausea, or vomiting are present •for longer than one week

Ask A Doctor Before Use If You Have

Noticed a sudden change in bowel habits that lasts over two weeks.

Ask A Doctor Or Pharmacist Before Use If You Are

Taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

Stop Use And Ask A Doctor If

  • •you have rectal bleeding •you fail to have a bowel movement after use of this productThese may indicate a serious condition.

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

  • •may be taken once daily or in divided doses •give dose in 1/2 glass of milk, fruit juice or infant formula to mask bitter taste and prevent throat irritationadults and children over 121 to 7 teaspoonschildren 2 to under 121 to 3 teaspoonschildren under 2ask a doctor

Other Information

  • •each teaspoon contains: sodium 5 mg •shake well before using •store at controlled room temperature 15° - 30°C (59° - 86°F) •dispense contents with a child resistant closure in a tight, light resistant container as defined in the USP •store in an upright position

Inactive Ingredients

D&C Red #33, methylparaben, natural & artificial vanilla flavor, poloxamer 181, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium benzoate. Sodium citrate may be used to adjust pH.

* Please review the disclaimer below.