Active Ingredient (In Each Softgel)
Docusate Sodium 250 mg
Extra Strength Stool Softener Laxative
FDA Label NDC 53808-0902
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by State Of Florida Doh Central Pharmacy for the product Extra Strength Stool Softener Laxative (NDC 53808-0902). 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 softgel), purpose, uses, do not use, ask a doctor before use if, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Stool softener
Uses
- for the prevention of dry, hard stools
- for relief of occasional constipation
- this product generally produces a bowel movement within 12 to 72 hours
Do Not Use
- if you are currently taking mineral oil, unless directed by a doctor
- when abdominal pain, nausea, or vomiting are present
- for more than 1 week, unless directed by a doctor
Ask A Doctor Before Use If
you notice a sudden change in bowel habits that persists over a period of 2 weeks.
Stop Use And Ask A Doctor If
- you have rectal bleeding
- you fail to have a bowel movement after use
These could be signs of 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
- adults and children 12 years of age and over: take1 softgel daily or as directed by a doctor
- children under 12 years of age: take as directed by a doctor
Other Information
- each softgel contains: sodium 15 mg
- store between 15°-30°C (59°-86°F)
Inactive Ingredients
edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special
Questions Or Comments?
1-800-645-2158
Distributed by: Rugby Laboratories
31778 Enterprise Drive
Livonia, MI 48150
www.rugbylaboratories.com
This Product was Repackaged By:
State of Florida DOH Central Pharmacy
104-2 Hamilton Park Drive
Tallahassee, FL 32304
USA
And supplied by State of Florida DOH Central Pharmacy as follows:
| NDC | Strength | Quantity/Form | Color | Source Prod. Code |
| 53808-0902-1 | 250 MG | 30 Capsules in a Blister Pack | orange | 0536-3757 |
Package Label
Label Image for 53808-0902
250mg
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