FDA Label for Stool Softener Stimulant Laxative
View Indications, Usage & Precautions
Stool Softener Stimulant Laxative Product Label
The following document was submitted to the FDA by the labeler of this product Quality Choice (chain Drug Marketing Association). 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 told to do so by a doctor
- if you are now taking mineral oil, unless told to do so 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.
adults and children 12 years and older | take 2-4 tablets daily |
childrens 6 to under 12 years of age | take1-2 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 20 mg
- each tablet contains: sodium 6 mg VERY LOW SODIUM
- store at 25°C(77°F), protect from heat, light, and moisture
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 1-248-449-9300 Monday-Friday 9AM-5PM EST
Principal Display Panel
†Compare to the Active Ingredients in Peri-Colace®
STOOL SOFTENER Plus Stimulant Laxative
Docusate sodium, 50 mg
Sennosides, 8.6 mg
Effective
Reliable
Comfortable
TABLETS
†This product is not manufactured or distributed by Purdue Products L.P., Distributor of Peri-Colace®.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
Distributed by C.D.M.A. Inc.©
43157 W. Nine Mile
Novi, MI 48376-0995
Product Label
Quality Choice Stool Softener Red Tablet
* Please review the disclaimer below.