Active Ingredient (In Each Softgel)
Docusate Sodium 100 mg
Stool Softener Capsule, Liquid Filled
FDA Label NDC 57896-411
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Geri-care Pharmaceutical Corp for the product Stool Softener (NDC 57896-411). 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 a period of 2 weeks
• are presently taking mineral oil
Stop use and ask a doctor if
• you have rectal bleeding or fail to have a bowel movement.
These could be signs of a serious condition.
• you need to use a laxative for longer than 1 week
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
- 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 5 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
citric acid, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, PEG, propylene glycol, purified water, sorbitol sorbitan
solution, white edible ink.
Questions Or Comments?
1-800-540-3765
Package Label
1 (411)
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