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 Cvs. 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.
Other
DRUG FACTS
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
Otc - Active Ingredient
Otc - Purpose
| Active ingredients (in each softgel) | Purpose |
| Docusate sodium 50 mg | Stool softener |
| Sennosides 8.6 mg | Stimulant Laxative |
Uses
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 6-12 hours
Warnings
Warnings
Otc - Do Not Use
Do not use
- laxative products for longer than 1 week unless told to do so by a doctor
- if you are presently taking mineral oil, unless told to do so by a doctor
Otc - Ask 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
Otc - Stop Use
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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 of age or over | take 2-4 softgels daily |
| children 6 to under 12 years of age | take 1-2 softgels daily |
| children 2 to under 6 years of age | take upto 1 softgel daily |
| children under 2 | ask a doctor |
Other Information
- each softgel contains: calcium 2 mg and sodium 3 mg
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- Keep tightly closed
Inactive Ingredients
Aerosil, beeswax, FD&C Red No.40, gelatin, glycerin, light liquid paraffin, povidone (PVP K-30), purified water, sodium carboxymethylcellulose, sorbitol solution, soya lecithin, titanium dioxide
Questions?
Call 1-888-333-9792 Monday-Friday 9AM-5PM EST
Principal Display Panel
♥CVSHealth™
Compare to the
active ingredients in
COLACE® 2-IN-1*
Liquid Filled Softgels
NDC 69842-319-60
Stool Softener
DOCUSATE SODIUM, 50 mg
SENNOSIDES, 8.6 mg
Plus stimulant laxative
Package Contains One Bottle
60 SOFTGELS
Actual Size
*This product is not manufactured or distributed by Purdue Products L.P., owner of the
registered trademark COLACE® 2-IN-1.
* Please review the disclaimer below.