Docusate Sodium
Safecor Health, Llc
Human Otc Drug
NDC 48433-220Docusate Sodium is a human otc drug labeled by 'Safecor Health, Llc'. National Drug Code (NDC) number for Docusate Sodium is 48433-220. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Docusate Sodium drug includes Docusate Sodium - 50 mg/5mL . The currest status of Docusate Sodium drug is Active.
Drug Information:
| Drug NDC: | 48433-220 |
| 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: | Docusate Sodium |
| 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: | Safecor Health, 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 Sep, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 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, 2024 |
| 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: | Safecor Health, 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. |
| UPC: | 0348433220405
|
| UPC stands for Universal Product Code. |
| 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 |
|---|
| 48433-220-10 | 10 mL in 1 CUP, UNIT-DOSE (48433-220-10) | 01 Sep, 2021 | 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
Product Elements:
Docusate sodium docusate sodium docusate sodium docusate fd&c red no. 40 methylparaben poloxamer 124 polyethylene glycol, unspecified propylene glycol propylparaben water sodium benzoate sodium citrate sucralose
Indications and Usage:
Use: relief of occasional constipation
Warnings:
Warnings: do not use * when abdominal pain, nausea, or vomiting are present * for a period longer than 1 week unless directed by a doctor ask a doctor before use if you * have noticed a sudden change in bowel habits that persist over a period of 2 weeks * are taking mineral oil stop use and ask a doctor if you have rectal bleeding or failure to have a bowel movement within 3 days. these could be signs of a serious condition. * a skin rash occurs * you experience throat irritation if pregnant or breast feeding , ask a health care professional before use. keep this and all drugs out of reach of children . in case of overdose, get medical help or contact a poison control center immediately. in case of eye contact, flush with water.
Do Not Use:
Warnings: do not use * when abdominal pain, nausea, or vomiting are present * for a period longer than 1 week unless directed by a doctor ask a doctor before use if you * have noticed a sudden change in bowel habits that persist over a period of 2 weeks * are taking mineral oil stop use and ask a doctor if you have rectal bleeding or failure to have a bowel movement within 3 days. these could be signs of a serious condition. * a skin rash occurs * you experience throat irritation if pregnant or breast feeding , ask a health care professional before use. keep this and all drugs out of reach of children . in case of overdose, get medical help or contact a poison control center immediately. in case of eye contact, flush with water.
Dosage and Administration:
Directions: * must be given in a 6 oz to 8 oz glass of milk or fruit juice to prevent throat irritation * shake well before using * do not exceed recommended dose * may be taken in one to four equally divided oral doses each day * take maximum dose daily until first bowel movement, dosage should then be reduced according to individual response adults and children 12 years of age and over 5 ml (1 teaspoon) to 40 ml (8 teaspoons) or as directed by a doctor children 6 to 12 years of age 4 ml to 15 ml (3 teaspoons) or as directed by a doctor children 3 to 6 years of age 2 ml to 6 ml or as directed by a doctor children under 3 years of age 1 ml to 4 ml or as directed by a doctor 1 teaspoon = 5 ml other information: each teaspoon (5 ml) contains: sodium 5 mg. store at room temperature 20°c-25°c (68°f-77°f); excursions between 15°c-30°c (59°f-86°f) are allowed. protect from excessive heat. protect from light. for more info call 1-800-447-1006. inactive ingredients: fd&
Read more...c red #40, flavor, methylparaben, poloxamer, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium benzoate, sodium citrate, and sucralose. ndc: 48433-220-10 docusate sodium liquid 100 mg/10 ml unit dose cup mfd. in the u.s.a. distributed by: safecor health, llc 4060 business park drive, columbus, oh 43204 rev: 11/2020 pn5473 3 4843322010 8
Stop Use:
Stop use and ask a doctor if you have rectal bleeding or failure to have a bowel movement within 3 days. these could be signs of a serious condition. * a skin rash occurs * you experience throat irritation
Package Label Principal Display Panel:
Principal display panel - box label safecor health docusate sodium liquid 100 mg / 10 ml contains 40 (10 ml) unit dose cups see monograph for complete drug information. ndc: 48433-220-40 qty: 40 lot: 21a0079 exp: 2023-03-31 store at room temperature 20°c-25°c (68°f-77°f); excursions between 15°c-30°c (59°f-86°f) are allowed. protect from excessive heat. protect from light. this package design is not child resistant. for institutional use only. shake well before use. 3 48433 22040 5 pkg by: safecor health, llc columbus, oh 43204 questions or comments: call 1-800-447-1006 gtin: 00348433220405 sn: 212802331 exp; 2023-03-31 lot 21a0079 pn5689.c principal display panel - box label
Principal display panel - lid label delivers 1 0 ml ndc 48433-220-10 docusate sodium liquid 100 mg/10ml shake well 348433220108 pkg by: safecor health, llc columbus, oh 43204 pn5618.b principal display panel - lid label