FDA Label for Gentle Stool Softener
View Indications, Usage & Precautions
Gentle Stool Softener Product Label
The following document was submitted to the FDA by the labeler of this product Rite Aid Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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 & over | take 1–3 softgels daily |
| children 2 to under 12 years of age | take 1 softgel daily |
| children under 2 years of age | ask 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?
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