Active Ingredient(S)
Docusate sodium 100mg
Stool Softener Capsule, Liquid Filled
FDA Label NDC 69168-424
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Allegiant Health for the product Stool Softener (NDC 69168-424). 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(s), purpose, use(s), do not use, ask a doctor before use if, stop use and ask a doctor if, pregnancy/breastfeeding, 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
Use(S)
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 12 to 72 hours
Do Not Use
- if you are presently taking mineral oil, unless told to do so by a doctor
Ask A Doctor Before Use If
- stomach pain
- nausea
- vomiting
- notice a sudden change in bowel habits that lasts over 2 weeks
Stop Use And Ask A Doctor If
- you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
- you need a laxative for more than 1 week
Pregnancy/Breastfeeding
ask a health professional before use.
Keep Out Of Reach Of Children
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
Take only by mouth.
Adults and children 12 years and over: take 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses.
Children 2 to under 12 years of age: take 1 softgel daily
Children under 2 years of age: ask a doctor
Other Information
- each softgel contains: sodium 5mg
- VERY LOW SODIUM
- do not use if imprinted safety seal under cap is broken or missing
Storage
Store at room temperature 15°-30°C (59°-86°F), protect from excessive humidity.
Inactive Ingredients
Anhydrous citric acid, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol,
propylene glycol, purified water, sorbitol sorbitan solution and white edible ink.
Questions
Call 1-888-952-0050 Monday to Friday 9am-5pm
Principal Display Panel
Stool Softener (424 Stool Softener Single Tone 1)
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