FDA Label for Stool Softener Plus Stimulant Laxative
View Indications, Usage & Precautions
Stool Softener Plus Stimulant Laxative Product Label
The following document was submitted to the FDA by the labeler of this product The Kroger Co.. 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
- for overnight relief from 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 now 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
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.
adult and children 12 years and over | take 2-4 tablets daily |
children 6 to under 12 years of age | take 1-2 tablets daily |
children 2 to under 6 yearsof 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
carnauba wax*, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, maltodextrin*, microcrystalline cellulose, polyethylene glycol*, polyvinyl alcohol*, sillicon dioxide, sodium benzoate*, stearic acid, talc*, titanium dioxide
*contains one or more of these ingredients
Questions Or Comments?
Call 1-800-632-6900
Principal Display Panel
COMPARE TO the active ingredients of COLACE® 2-IN-1 **See side panel
Stool Softener + Stimulant Laxative
Docusate Sodium, 50 mg
Sennosides, 8.6 mg
FOR OVERNIGHT RELIEF OF OCCASIONAL CONSTIPATION
- Effective
- Reliable
- Comfortable
TABLETS
**Colace® 2-IN1 is a registered trademark of Avrio Health LP., Stamford, CT 06901. Avrio Health LP. is not affiliated with the Kroger Co, or this product
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202
Product Label
KROGER Stool Softener plus Stimulant Laxative
* Please review the disclaimer below.