Senna-s Tablet, Film Coated
FDA Label NDC 70677-1246
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Strategic Sourcing Services, Llc for the product Senna-s (NDC 70677-1246). 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 tablet) docusate sodium 50 mg sennosides 8.6 mg, purposestool softner laxative, uses• relieves occasional constipation (irregularity) • generally produces bowel movement in 6-12 hours, warnings do not use • if you are now taking mineral oil, unless directed by a doctor • 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 lasts over a period of 2 weeks, stop use and ask a doctor ifyou 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., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients (In Each Tablet) Docusate Sodium 50 Mg Sennosides 8.6 Mg
Purposestool Softner Laxative
Uses• Relieves Occasional Constipation (Irregularity) • Generally Produces Bowel Movement In 6-12 Hours
Warnings Do Not Use • If You Are Now Taking Mineral Oil, Unless Directed By A Doctor • 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 Lasts Over A Period Of 2 Weeks
Stop Use And Ask A Doctor Ifyou 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 1(800)222-1222
Directions• Take Preferably At Bedtime Or As Directed By A Doctor Age Starting Dosage Maximum Dosage Adults And Children 12 Years Of Age Or Over 2 Tablets Once A Day 4 Tablets Twice A Day Children 6 To Under 12 Years 1 Tablet Once A Day 2 Tablets Twice A Day Children 2 To Under 6 Years 1/2 Tablet Once A Day 1 Tablet Twice A Day Children Under 2 Years Ask A Doctor Ask A Doctor
Other Information• Each Tablet Contains:Calcium 20 Mg, Sodium 6 Mg • Store At 25°C (77°F); Excursions Permitted Between 15°-30°C (59°-86°F)
Inactive Ingredients: Carnauba Wax, Colloidal Silicon Dioxide, Croscarmellose Sodium, Dicalcium Phosphate, D&C Yellow No. 10, Fd&C Yellow No. 6, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Maltodextrin, Polyethylene Glycol, Purified Water, Sodium Benzoate, Stearic Acid, Titanium Dioxide
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