Active Ingredient (In Each Softgel)
Docusate Sodium 100 mg
Stool Softener Capsule, Liquid Filled
FDA Label NDC 30142-407
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kroger Company for the product Stool Softener (NDC 30142-407). 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 lasts longer than 2 weeks
• are presently taking mineral oil
Stop use and ask a doctor if
• you need to use a laxative longer than 1 week
• you have rectal bleeding or fail to have a bowel movement. 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
- Take only by mouth.
| Adults and children 12
years of age and older | 1 to 3 capsules daily.
May be taken as a single daily dose or in divided doses. |
| Children 2 to under 12
years of age | 1 capsule daily |
| Children under 2 years | Ask a doctor |
Other Information
• each softgel contains: sodium 7 mg. very low sodium
• store at 59°-77°F (15°-25°C)
• keep tightly closed
• product of Romania
• Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
Inactive Ingredients
gelatin, glycerin, PEG, purified water, sorbitol special. Contains less that 1% of D&C red #33, edible ink, FD&C red #40, FD&C yellow #6 (sunset yellow), titanium dioxide
Package Label
* Please review the disclaimer below.
