Active Ingredient (In Each S Oftgel)
Docusate Sodium 100 mg
Docusate Sodium 100mg
FDA Label NDC 84328-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shandong Rosemed Biooharm Llc for the product Docusate Sodium 100mg (NDC 84328-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each s oftgel), purpose, uses, warnings, directions, other information, inactive ingredients, dosage & administraton, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Stool softener laxative
Uses
- for temporary relief of occasional constipation and irregularity
- this product generally produces bowel movement in 12 to 72 hours
Warnings
Ask a doctor before use if you have
- stomach pain, nausea or vomitting
- a sudden change in bowel habits that lasts more than 2 weeks
- you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
- you need to use a laxative for more than 1 week
Ask a doctor or pharmacist before use if you are presently taking mineral oil
Stop use and ask a doctor if
If pregnant or breast-feeding, ask a health professional before use.
Directions
take with a glass of water
| adults and children 12 years and over | 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses. | |
| children 2 and under 12 years of age | 1 softgel daily | |
| children under 2 years of age | ask a doctor |
Other Information
- each softgel contains: sodium 5 mg
- store at room temperature 15°-30°C (59°-86°F)
- protect from excessive humidity
Inactive Ingredients
FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol special, citric acid, purified water and white edible ink
Dosage & Administraton
each softgel contains: sodium 5 mg
store at room temperature 15°-30°C (59°-86°F)
protect from excessive humidity
Indications & Usage Section
| adults and children 12 years and over | 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses. |
| children 2 and under 12 years of age | 1 softgel daily |
| children under 2 years of age | ask a doctor |
Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center right away.
Drug Label Information
DOCUSATE SODIUM CAPSULES, 100 mg
Quantity : 20000 Capsules
NDC. No : 84328-001
IMPORTANT:
Inspect immediate upon receipt.
This is a bulk shipment, intended for further processing only.
Protect from heat, humidity, and light. Do not refrigerate.
Store at 15-30°C (59-86°F)
CAUTION : FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING
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