FDA Label for Senna/docusate Sodium
View Indications, Usage & Precautions
Senna/docusate Sodium Product Label
The following document was submitted to the FDA by the labeler of this product Medsource Pharmaceuticals. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active Ingredients (in each tablet)
Docusate Sodium 50 mg
Sennosides 8.6 mg
Otc - Purpose
Purpose
Stool Softener
Stimulant Laxative
Indications & Usage
Uses relieves occasional constipation (irregularity). This product generally produces a bowel movement in 6 to 12 hours.
Warnings
Warnings
Ask a doctor before use if you have
- Stomach pain
- Nausea
- Vomiting
- A sudden change in bowel habits that lasts over a period of 2 weeks.
DO NOT USE
Laxative products for longer than 1 week unless directed by a doctor
If you are presently taking mineral oil, unless directed by a doctor
Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are presently taking mineral oil.
Dosage & Administration
Take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided dose.
Age | Dosage |
Adults and children 12 years of age and older | Take 2-4 tablets daily |
Children 6 to under 12 years | Take 1-2 tablets daily |
Children 2 to 6 years | Take up to 1 tablet daily |
Children under 2 years | Do not use |
Generic Section
Other information
- Each tablet contains: sodium 6 mg/tablet VERY LOW SODIUM
- Each tablet contains: calcium 20 mg/tablet.
- Store at 20° - 25°C (68° -77°F); excursions permitted to 15°-30° (59°-86°F). [See USP Controlled Room Temperature]
Inactive Ingredient
Inactive Ingredients: Carnauba Wax, Colloidal Silicon Dioxide, Croscarmellose Sodium, Dibasic Calcium Phosphate Dihydrate, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, tapioca starch*, tartaric acie*, and titanium dioxide. *may contain these ingredients.
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.
Questions
Questions? To Report Serious Adverse Effects Call: (800)616-2471
Distributed By:
Major® Pharmaceuticals
17177 N Laurel Park Dr., Suite 233
Livonia, MI 48152 USA
LHC51790417
Package Label.Principal Display Panel
* Please review the disclaimer below.
