Active Ingredient (In Each Softgel)
Docusate Sodium 100 mg
Stool Softener Capsule, Liquid Filled
FDA Label NDC 69618-086
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Reliable 1 Laboratories Llc for the product Stool Softener (NDC 69618-086). 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
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
• noticed a sudden change in bowel habits that lasts for over 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
- do not exceed recommended dose
- take only by mouth
- adults and children 12 years and older: take 1-3 softgels daily, usually 1 softgel daily after the first bowel movement, or as directed by a doctor.
- children under 12: 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
•
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, sorbitol special, purified water.
Questions Or Comments?
1-800-540-3765
Package Label
1 (401 Rel)
* Please review the disclaimer below.
