FDA Label for Stool Softener
View Indications, Usage & Precautions
Stool Softener Product Label
The following document was submitted to the FDA by the labeler of this product Strategic Sourcing Services Llc. 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.
Active Ingredients (In Each Tablet)
Docusate sodium 50 mg
Sennosides 8.6 mg
Purpose
Stool softener
Stimulant laxative
Uses
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 6 to12 hours
Do Not Use
- laxative products for longer than 1 week unless directed by a doctor
- 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 a period of 2 weeks
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.
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 only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses.
adults and children 12 years and older | take 2-4 tablets daily |
children 6 to under 12 years of age | take 1-2 tablets daily |
children 2 to under 6 years of age | take up to 1 tablet daily |
children under 2 | ask a doctor |
Other Information
- each tablet contains: calcium 30 mg
- each tablet contains: sodium 6 mg VERY LOW SODIUM
- store at 25°C (77°F); excursions permitted between 15-30°C (59-86°F)
Inactive Ingredients
croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, talc, titanium dioxide
Questions Or Comments?
Call 1-833-358-6431 Monday to Friday 9:00am to 7:00pm EST
Principal Display Panel
COMPARE TO COLACE® 2-IN-1 ACTIVE INGREDIENTS*
Stool Softener
Docusate sodium 50 mg
Sennosides 8.6 mg
STOOL SOFTENER
STIMULANT LAXATIVE
TABLETS
*This product is not manufactured or distributed by Avrio Health L.P., distributor of Colace® 2-IN-1.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
Distributed by: McKesson Corp.,
via SSSl, Memphis, TN 38141
www.fosterandthrive.com
Product Label
FOSTER & THRIVE Stool Softener
* Please review the disclaimer below.