Cvs Health Regular Strength Senna Laxative Softgel
FDA Label NDC 51316-901
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 Regular Strength Senna Laxative Softgel (NDC 51316-901). 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 ingredient (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 Ingredient (In Each Softgel)
Sennosides 8.6 mg
Purpose
Laxative
Uses
• relieves occasional constipation (irregularity)
• generally produces a bowel movement in 6-12 hours
Warnings
Do not use
• laxative products for longer than 1 week 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 continues 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.
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 preferably at bedtime or as directed by a doctor.
| Age | Starting Dosage | Maximum Dosage |
| adults and children 12 years of age and over | 2 softgels once a day | 4 softgels twice a day |
| children 6 to under 12 years | 1 softgel once a day | 2 softgels twice a day |
| children under 6 years of age | ask a doctor | ask a doctor |
Other Information
• store at room temperature between 20°-25°C (68°-77°F)
Inactive Ingredients
black Iron oxide, fumaric acid, gelatin, glycerin, lecithin, methyl paraben, purified water, red Iron oxide, sorbitol 70% solution, soybean oil, yellow bees wax
Questions?
Call 1-800-SHOP-CVS
Packaging
Cvs-901 (5131690106)
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