Otc - Active Ingredient
Each tablet contains: Sennosides 8.6 mg
Senna Time
FDA Label NDC 71335-0865
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bryant Ranch Prepack for the product Senna Time (NDC 71335-0865). 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, how supplied, 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 dayChildren 6 to under 12 years - starting dosage: 1 tablet once a day Maximum dosage: 2 tablets twice a dayChildren 2 to under 6 years - starting dosage: 1/2 tablet once a day Maximum dosage: 1 tablet twice a dayChildren 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
How Supplied
Product: 71335-0865
NDC: 71335-0865-1 100 TABLET, COATED in a BOTTLE
NDC: 71335-0865-2 60 TABLET, COATED in a BOTTLE
NDC: 71335-0865-3 120 TABLET, COATED in a BOTTLE
NDC: 71335-0865-4 56 TABLET, COATED in a BOTTLE
NDC: 71335-0865-5 30 TABLET, COATED in a BOTTLE
NDC: 71335-0865-6 90 TABLET, COATED in a BOTTLE
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