Gentle Stool Softener
FDA Label NDC 11822-1574

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid Corporation for the product Gentle Stool Softener (NDC 11822-1574). 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 drug facts, active ingredient (in each tablet), purpose, uses, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient (In Each Tablet)

Docusate sodium 100 mg

Purpose

Stool softener

Uses

• relieves occasional constipation (irregularity) • generally produces bowel movement in 12–72 hours

Otc - Do Not Use

Do not use if you are presently taking mineral oil, unless told to do so by a doctor

Otc - Ask Doctor

Ask a doctor before use if you have • fever • mucus in the stool

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are if you have
• stomach pain • nausea • vomiting • noticed a sudden change in bowel habits that lasts over 2 weeks

Otc - Stop Use

Stop use and ask a doctor if • 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 stool softener
laxative for more than 1 week

Otc - Pregnancy Or Breast Feeding

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. (1-800-222-1222)

Directions

• take only by mouth. Doses may be taken as a single daily dose or in divided doses.

adults & children 12 years of age & overtake 1–3 softgels daily
children 2 to under 12 years of agetake 1 softgel daily
children under 2 years of ageask a doctor

Other Information

• store at 25°C (77°F); excursions permitted between 15°–30°C (59°–86°F) • Keep tightly closed

Inactive Ingredients

FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol-400, povidone, propylene glycol, purified water, sorbitol solution, titanium dioxide

Questions Or Comments?

1-888-333-9792

Principal Display

* Please review the disclaimer below.