FDA Label for Stool Softener Laxative
View Indications, Usage & Precautions
Stool Softener 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
- 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 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 may indicate 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 21mg
- each tablet contains: sodium 5 mg VERY LOW SODIUM
- store at 25°C(77°F), excursion permitted between 15-30°C (59-86°F)
Inactive Ingredients
carnauba wax, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sillicon dioxide, sodium benzoate, stearic acid, titanium dioxide
Questions Or Comments?
Call 1-800-935-2362 Monday-Friday 9AM-5PM EST
Principal Display Panel
*Compare to the Active Ingredients in Colace® 2-IN-1
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 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 C.D.M.A. Inc.©
43157 W. 9 Mile Rd
Novi, MI 48375
Product Label
QUALITY CHOICE Stool Softener Laxative
* Please review the disclaimer below.