FDA Label for Stool Softener With Stimulant Laxative
View Indications, Usage & Precautions
Stool Softener With Stimulant Laxative Product Label
The following document was submitted to the FDA by the labeler of this product P & L Development, 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 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 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 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 |
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 21 mg
- each tablet contains: sodium 5 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 red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, sodium benzoate, stearic acid, talc, titanium dioxide
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
stool softener + stimulant laxative
docusate sodium 50 mg
(stool softener )
sennosides 8.6 mg
(stimulant laxative)
tablets
*Compare to the active ingredients in Colace® 2-IN-1
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
*This product is not manufactured or distributed by Avrio Health LP., distributor of Colace® 2-IN-1
Distributed by: PL Developments
200 Hicks Street, Westbury, NY 11590
Product Label
WELLNESS BASICS Stool softener + Stimulant Laxative
* Please review the disclaimer below.