Active Ingredient (In Each Softgel)
Docusate sodium 250 mg
Stool Softener Laxative Capsule, Liquid Filled
FDA Label NDC 71335-2313
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bryant Ranch Prepack for the product Stool Softener Laxative (NDC 71335-2313). 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 you have, 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 laxative
Uses
- relieves occasional constipation (irregularity)
- this product generally produces a bowel movement within 12 to 72 hours
Do Not Use
if you are presently taking mineral oil, unless directed by a doctor.
Ask A Doctor Before Use If You Have
- stomach pain
- nausea
- vomiting
- noticed a sudden change in bowel habits that last over 2 weeks
Stop Use And Ask A Doctor If
- 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
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 (1-800-222-1222) right away.
Directions
- adults and children 12 years of age and over: take 1 softgel daily or as directed by a doctor
- children under 12 years of age: ask a doctor
Other Information
- each softgel contains: sodium 13 mg
- store between 20-25°C(68-77°F); excursions permitted between 15-30°C (59-86°F)
Inactive Ingredients
anhydrous citric acid, FD&C red #40, FD&C yellow #6, gelatin, glycerin, isopropyl alcohol, lecithin, mannitol, mineral oil, polyethylene glycol, propylene glycol, purified water, sorbitan, sorbitol, white ink
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
How Supplied
Docusate Sodium 250mg Softgel Capsules
- NDC 71335-2313-1: 30 in a BOTTLE
- NDC 71335-2313-2: 60 in a BOTTLE
- NDC 71335-2313-3: 100 in a BOTTLE
- NDC 71335-2313-4: 7 in a BOTTLE
- NDC 71335-2313-5: 90 in a BOTTLE
Repackaged/Relabeled by:
Bryant Ranch Prepack
Burbank, CA 91504
Package Label.Principal Display Panel
Docusate Sodium 250mg Softgel Capsules
Label (Lbl713352313)
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