Active Ingredient (In Each Softgel)
Docusate Sodium 250 mg
Stool Softener Capsule, Liquid Filled
FDA Label NDC 71335-1677
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 (NDC 71335-1677). 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, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, 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)
- generally produces bowel movement in 12 to 72 hours
Warnings
Ask a doctor before use if you
- have stomach pain, nausea, or vomiting
- have a sudden change in bowel habits that persists over a period of 2 weeks
- are presently taking mineral oil
- you need to use a laxative longer than 1 week
- you have rectal bleeding or fail to have a bowel movement.
Stop use and ask a doctor if
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before
use.
Otc - Keep Out Of Reach Of Children
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 and older: take 1 softgel daily or as directed by a doctor
- children under 12: do not use
- do not exceed recommended dose
Other Information
- each softgel contains: sodium 15 mg
- store at 59°-77°F (15°-25°C)
- keep tightly closed
- product of Romania
- Package not child resistant
- Tamper Evident: Do not use if imprinted seal under cap is missing or broken
Inactive Ingredients
FD&C red #40, FD&C yellow #6 (sunset yellow),
gelatin, glycerol, PEG, purified water
Questions Or Comments?
1-800-540-3765
How Supplied
Product: 71335-1677
NDC: 71335-1677-1 30 CAPSULE, LIQUID FILLED in a BOTTLE
NDC: 71335-1677-2 60 CAPSULE, LIQUID FILLED in a BOTTLE
NDC: 71335-1677-3 100 CAPSULE, LIQUID FILLED in a BOTTLE
NDC: 71335-1677-4 7 CAPSULE, LIQUID FILLED in a BOTTLE
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