Active Ingredients (In Each Tablet)
Docusate Sodium 50 mg
Sennosides 8.6 mg
Senna-s Tablet
FDA Label NDC 84324-013
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Nuvicare Llc for the product Senna-s (NDC 84324-013). 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 active ingredients (in each tablet), purpose, uses:, warnings:, directions, other information, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Docusate Sodium............... Stool softener
Sennosides........................Laxative
Uses:
- Relieves occasional constipation (irregularity).
- Generally produces a bowel movement in 6 to 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.
Directions
Take preferably at bedtime or as directed by a doctor.
age | starting dosage | maximum dosage |
adults & children 12 years of age and 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 19.92 mg, Sodium 5.61 mg VERY LOW SODIUM
- store at 25°C (77°F) excursions permitted between15°-30°C (59°-86°F)
Inactive Ingredients
Croscarmellose Sodium, Colloidal Silicon Dioxide, Dicalcium Phosphate, F D & C Red, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Maltodextrin, Polyethylene Glycol, Stearic acid Powder, Titanium Dioxide.
Questions Or Comments?
Call 1 (718) 337-8733 or visit: [email protected]
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