NDC 61919-888 Docusate Sodium
Product Information
Usage Information
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) | RED (C48326 - REDDISH) |
| Shape | CAPSULE (C48336) |
| Size(s) | 12 MM |
| Imprint(s) | SCU1 |
| Score | 1 |
Product Packages
NDC 61919-888-30
Package Description: 30 TABLET in 1 BOTTLE
NDC 61919-888-60
Package Description: 60 TABLET in 1 BOTTLE
NDC 61919-888-71
Package Description: 100 TABLET in 1 BOTTLE
Product Details
Docusate Sodium is product labeled by Direct Rx. The product's dosage form is and is administered via form.
What are Docusate Sodium Active Ingredients?
The following is the list of active ingredients in this product. 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 (UNII: F05Q2T2JA0)
- DOCUSATE (UNII: M7P27195AG) (Active Moiety)
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 code indicates a single concept unique identifier (RXCUI) is 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.
- FD&C RED NO. 40 (UNII: WZB9127XOA)
- FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
- GELATIN (UNII: 2G86QN327L)
- GLYCERIN (UNII: PDC6A3C0OX)
- POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
- WATER (UNII: 059QF0KO0R)
- SORBITOL (UNII: 506T60A25R)
* Please review the disclaimer below.
Docusate Sodium 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
- OTC - ACTIVE INGREDIENT SECTION
- OTC - PURPOSE SECTION
- INDICATIONS & USAGE SECTION
- OTC - DO NOT USE SECTION
- OTC - ASK DOCTOR SECTION
- OTC - STOP USE SECTION
- OTC - PREGNANCY OR BREAST FEEDING SECTION
- OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- DOSAGE & ADMINISTRATION SECTION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT SECTION
- OTHER
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Otc - Active Ingredient Section
Docusate sodium 100 mg
Otc - Purpose Section
Stool softener
Indications & Usage Section
relieves occasional constipation (irregularity)
generally produces bowel movement in 12 to 72 hours
Otc - Do Not Use Section
Do not use if you are presently taking mineral oil, unless told to do so by a doctor
Otc - Ask Doctor Section
stomach pain
nausea
vomiting
noticed a sudden change in bowel habits that lasts over 2 weeks
Otc - Stop Use Section
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 laxative for more than 1 week
Otc - Pregnancy Or Breast Feeding Section
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children Section
In case of overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration Section
doses may be taken as a single daily dose or in divided doses
Other Safety Information
each softgel contains: sodium 5 mg VERY LOW SODIUM
store at 15°-30°C (59°-86°F)
keep tightly closed
You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.
Inactive Ingredient Section
FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol 400, purified water, sorbital special
Other
Manufactured for:
QUALITEST PHARMACEUTICALS
HUNTSVILLE, AL 35811
R0 07/2011
015021CPR
Package Label.Principal Display Panel
* Please review the disclaimer below.