Otc - Active Ingredient
| Each tablet contains: Sennosides 8.6 mg |
Senna
FDA Label NDC 11822-3311
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid for the product Senna (NDC 11822-3311). 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 otc - active ingredient, otc - keep out of reach of children, otc - purpose, indications & usage, dosage & administration, warnings, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 |
Otc - Purpose
PURPOSE: LAXATIVE |
Indications & Usage
| Relieves occasional constipation (irregularity;generally causes bowel movement in 6-12 hours |
Dosage & Administration
Directions:
Take preferably at bedtime or as directed by a doctor; if you do not have a comfortable bowel movement by the second day, increase dose by one tablet (do not exceed maximum dosage) or decrease dose until you are comfortable. Adults and children 12 years and over - starting dosage: 2 tablets once a day Maximum dosage: 4 tablets twice a day Children 6 to under 12 years - starting dosage: 1 tablet once a day Maximum dosage: 2 tablets twice a day Children 2 to under 6 years - starting dosage: 1/2 tablet once a day Maximum dosage: 1 tablet twice a day Children under 2 years - ask a doctor |
Warnings
| WARNINGS: Do not use laxative products for longer than 1 week unless directed by a doctor |
Inactive Ingredient
| Inactive Ingredients: croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil |
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