Cvs Health Stool Softener Plus Stimulant Laxative Softgel
FDA Label NDC 51316-903
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy, Inc. for the product Cvs Health Stool Softener Plus Stimulant Laxative Softgel (NDC 51316-903). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredients (in each softgel), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients (In Each Softgel)
Docusate sodium 50 mg
Sennosides 8.6 mg
Purpose
Stool softener
Stimulant laxative
Uses
• relieves occasional constipation (irregularity)
• generally produces bowel movement in 6 to 12 hours
Warnings
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
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.
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 and over | take 2-4 softgels daily |
| children 6 to under 12 years and over | take 1-2 softgels daily |
| children under 6 years of age | ask a doctor |
Other Information
• each softgel contains: sodium 4 mg
• store at room temperature between 20°-25°C (68°-77°F)
Inactive Ingredients
colloidal silicon dioxide, FD&C red #40, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide, yellow bees wax
Questions Or Comments?
Call 1-800-SHOP-CVS
Packaging
Cvs-903 (5131690306)
* Please review the disclaimer below.
