Active Ingredient (In Each Softgel)
Docusate Sodium 250 mg
Stool Softener
FDA Label NDC 17856-0443
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Atlantic Biologicals Corps for the product Stool Softener (NDC 17856-0443). 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 - do not use, ask a doctor before use if, 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
Uses
- for the prevention of dry, hard stools
- for relief of occasional constipation.
- this product generally produces a bowel movement within 12 to 72 hours.
Warnings - Do Not Use
- if you are currently taking mineral oil, unless directed by a doctor
- when abdominal pain, nausea, or vomiting are present
- for more than 1 week, unless directed by a doctor
Ask A Doctor Before Use If
you notice a sudden change in bowel habits that persists over a period of 2 weeks
Stop Use And Ask A Doctor If
- you have rectal bleeding
- you fail to have a bowel movement after use
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 right away.
Directions
- take 1 softgel daily or as directed by a doctor
adults and children over 12 years of age and over:
- : take as directed by a doctor children under 12 years of age
Other Information
- sodium 15 mg each softgel contains:
- store at controlled room temperature 15 - 30 C (59 - 86 F) oooo
- do not use if imprinted safety seal under cap is broken or missing
Inactive Ingredients
edible white ink, FD&C Red No# 40, FD&C Yellow No# 6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water and sorbitol special.
Questions Or Comments?
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