Senna Laxative Tablet
FDA Label NDC 70677-1247
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Strategic Sourcing Services Llc for the product Senna Laxative (NDC 70677-1247). 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 tablet) sennosides 8.6 mg, purpose laxative, uses • relieves occasional constipation (irregularity) • generally produces 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 lasts over 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 Ingredient (In Each Tablet) Sennosides 8.6 Mg
Purpose Laxative
Uses • Relieves Occasional Constipation (Irregularity) • Generally Produces 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 Lasts Over 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 (1-800-222-1222) Right Away.
Directions• Take Preferbly 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 ½ Tablet Once A Day Tablets Twice A Day Children 2 Years Ask A Doctor Ask A Doctor
Other Information
Other Information
• each tablet contains:calcium 24mg and sodium 3mg (Very Low Sodium)
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients Colloidal Silicon Dioxide, Croscarmellose Sodium, Dicalcium Phosphate, Hypromellose, Liquid Paraffin, Magnesium Stearate, Microcrystalline Cellulose, Maltodextrin, Purified Water, Sodium Lauryl Sulphate, Stearic Acid
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