Active Ingredient (In Each Softgel)
Docusate Sodium 50 mg
Sennosides 8.6 mg
Gencare-senna-s Softgel Capsule, Liquid Filled
FDA Label NDC 72090-054
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pioneer Life Sciences, Llc for the product Gencare-senna-s Softgel (NDC 72090-054). 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 ingredient (in each softgel), 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
age | starting dosage | maximum dosage |
adults & children 12 years of age and over | 2 softgels once a day | 4 softgels twice a day |
children 6 to under 12 years | 1 softgel once a day | 2 softgels twice a day |
children under 6 years | ask a doctor | ask a doctor |
Other Information
- Each softgel contains: Calcium 3 mg, Sodium 5 mg VERY LOW SODIUM
- store at 25°C (77°F) excursions permitted between15°-30°C (59°-86°F)
Inactive Ingredients
Polyethylene Glycol 400, Propylene Glycol, Yellow Beeswax, Povidone (PVPK-30), Colloidal silicon dioxide (Aerosil), Gelatin, Glycerin, Sorbitol Sorbitan Solution, FD & C Red No.40, FD & C Yellow No.6, Titanium Dioxide, Purified Water.
Questions Or Comments?
Call +1 (732) 994-2808 or email [email protected]
* Please review the disclaimer below.
