Senna Laxative
FDA Label NDC 79481-0059
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Meijer, Inc. for the product Senna Laxative (NDC 79481-0059). 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 stimulant laxative, uses ■ relieves occasional constipation (irregularity) ■ generally produces a bowel movement in 6 to 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., 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 Stimulant Laxative
Uses ■ Relieves Occasional Constipation (Irregularity) ■ Generally Produces A Bowel Movement In 6 To 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.
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 Preferably At Bedtime Or As Directed By A Doctor Age Starting Dosage Maximum Dosage Adults And 2 Tablets Once A Day 4 Tablets Twice A Day Children 12 Years Of Age And Over Children 6 To 1 Tablet Once A Day 2 Tablets Twice A Day Under 12 Years Children 2 To 1/2 Tablet Once A Day 1 Tablet Twice A Day Under 6 Years Children Under 2 Ask A Doctor Ask A Doctor Years
Other Information ■ Each Tablet Contains:Calcium 25 Mg, Sodium 3 Mg Very Low Sodium ■ Store At 25°C (77°F); Excursions Permitted Between 15°C-30°C (59°F-86°F)
Inactive Ingredientscolloidal Silicon Dioxide, Croscarmellose Sodium, Dicalcium Phosphate, Hypromellose, Liquid Paraffin, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Sodium Lauryl Sulfate, Stearic Acid
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