Active Ingredient (In Each Softgel)
DOCUSATE SODIUM 250 MG
Docusate Sodium, Extra Strength Capsule, Gelatin Coated
FDA Label NDC 80513-101
10 label sections · Submitted to the FDA by Advanced Rx Llc · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Advanced Rx Llc for the product Docusate Sodium, Extra Strength (NDC 80513-101). 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
- 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 presently taking mineral oil, unless directed by a doctor.
Ask a doctor before use if you have
- stomach pain
- nausea
- vomiting
- noticed a sudden change in bowel habits that lasts over 2 weeks
- you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
- you need to use a laxative for more than 1 week
Stop use and ask a doctor if
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 (1-800-222-1222) right away.
Directions
- adults and children 12 years of age and over: take 1 softgel daily or as directed by a doctor
- children under 12 years of age: ask a doctor
Other Information
- each softgel contains: sodium 20 mg
- Phenylketonurics: Contains phenylalanine 4 mg per softgel
- store at 15°- 25°C (59°- 77°F)
Inactive Ingredients
FD&C red #40, FD&C yellow #6, gelatin, glycerin, ink (edible), polyethylene glycol, propylene glycol, purified water, sorbitol.
Questions?
call 1-800-630-8895
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