Docu Liquid
Docusate Sodium
Akorn Operating Company Llc
Human Otc Drug
NDC 50383-771Docu Liquid also known as Docusate Sodium is a human otc drug labeled by 'Akorn Operating Company Llc'. National Drug Code (NDC) number for Docu Liquid is 50383-771. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Docu Liquid drug includes Docusate Sodium - 50 mg/5mL . The currest status of Docu Liquid drug is Active.
Drug Information:
| Drug NDC: | 50383-771 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Docu Liquid |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Docusate Sodium |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Akorn Operating Company Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Liquid |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | DOCUSATE SODIUM - 50 mg/5mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH NOT FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 01 Aug, 1997 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 05 May, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part334 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Akorn Operating Company LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1248119
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | F05Q2T2JA0
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 50383-771-16 | 473 mL in 1 BOTTLE (50383-771-16) | 01 Aug, 1997 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose stool softener laxative
Product Elements:
Docu liquid docusate sodium docusate sodium docusate d&c red no. 33 methylparaben polyethylene glycol 400 propylene glycol propylparaben sodium benzoate sodium citrate, unspecified form water poloxamer 181 natural and artificial flavor docu liquid docusate sodium docusate sodium docusate d&c red no. 33 methylparaben polyethylene glycol 400 propylene glycol propylparaben sodium benzoate sodium citrate, unspecified form water poloxamer 181 natural and artificial flavor
Indications and Usage:
Uses ⢠relieves occasional constipation ⢠generally produces bowel movement in 12-72
Warnings:
Warnings 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.
Do Not Use:
Warnings 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.
Dosage and Administration:
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
Package Label Principal Display Panel:
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. distributed by: akorn operating company llc gurnee, il 60031 net contents one pint (473 ml) container label
Package/label principal display panel delivers 10 ml ndc 50383-349-10 docu liquid (docusate sodium) 100 mg/ 10 ml stool softener laxative see insert barcode 3 5038334910 5 for institutional use only distributed by: akorn operating company llc gurnee, il 60031 rev. 349:01 04/22 unit dose lid