NDC 50383-771 Docu Liquid
Docusate Sodium Liquid Oral

Product Information

Docu Liquid is a human over the counter drug product labeled by Akorn Operating Company Llc. The generic name of Docu Liquid is docusate sodium. The product's dosage form is liquid and is administered via oral form.

Product Code50383-771
Proprietary Name 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.
Docu Liquid
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.
Docusate Sodium
Product Type 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.
Human Otc Drug
Dosage FormLiquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
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.
Akorn Operating Company Llc
Labeler Code50383
FDA Application Number 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.
part334
Marketing Category 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.
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
08-01-1997
Listing Expiration Date 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.
12-31-2023
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".
N
NDC Code Structure

What are the uses for Docu Liquid?


Product Characteristics

Color(s)PINK (C48328)
Flavor(s)VANILLA (C73421 - NATURAL AND ARTIFICIAL FLAVOR)

Product Packages

NDC 50383-771-16

Package Description: 473 mL in 1 BOTTLE

Price per Unit: $0.01494 per ML

Product Details

What are Docu Liquid Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • DOCUSATE SODIUM 50 mg/5mL - All-purpose surfactant, wetting agent, and solubilizer used in the drug, cosmetics, and food industries. It has also been used in laxatives and as cerumenolytics. It is usually administered as either the calcium, potassium, or sodium salt.

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

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)

* Please review the disclaimer below.

Patient Education

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.

Docu Liquid Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



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 product
  • These 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 irritation
  • adults and children over 12

    1 to 7 teaspoons

    children 2 to under 12

    1 to 3 teaspoons

    children under 2

    ask 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.


Questions Or Comments?



  • Call 1-800-262-9010
  • Mon - Thurs. 9:00 am - 4:30 pm EST, Fri. 9:00 am - 2:30 pm EST.

    Serious side effects associated with use of this product may be reported to this number.


Package/Label Principal Display Panel



NDC 50383-771-16

DOCU LIQUID

(Docusate Sodium 50 mg/5 mL)

STOOL SOFTENER LAXATIVE

TAMPER EVIDENT: FOR YOUR PROTECTION THE CHILD RESISTANT CAP HAS A PRINTED SAFETY SEAL AROUND THE NECK. DO NOT ACCEPT IF BROKEN OR MISSING.

Hi-Tech Pharmacal Co., Inc.

Amityville, NY 11701

NET CONTENTS ONE PINT (473 mL)


* Please review the disclaimer below.