Otc - Active Ingredient
Each Tablet contains:
Sennosides 15 mg
Sennosides Tablet, Sugar Coated
FDA Label NDC 49483-079
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Time Cap Laboratories, Inc for the product Sennosides (NDC 49483-079). 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, inactive ingredient, otc - purpose, dosage & administration, indications & usage, warnings, otc - keep out of reach of children, 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
Inactive Ingredient
INACTIVE INGREDIENTS:acacia, calcium sulfate anhydrous, carnauba wax, corn starch, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue#1, FD&C Red#40, FD&C Yellow#6, iron oxide, iron oxide black, iron oxide yellow, Kaolin, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol(PEG 400), povidone, Shellac, Sugar, Talc, Titanium dioxide
Otc - Purpose
stool softner, laxative
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 (not to 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 6 to under 12 years - starting dosage: 1/2 tablet once a day maximum dosage: 1 tablet twice a day
Children under 2 years - Ask a doctor
Indications & Usage
Uses:
Relieves occasional constipation (irregularity); generally causes bowel movement in 6-12 hours
Warnings
WARNINGS:
Do not use this product
If you are presently taking mineral oil, unless directed by a doctor
Laxative products for longer than 1 week unless directed by a doctor
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children. Incase of overdose, get medical help or contact a Poison Control Center right away.
Package Label.Principal Display Panel
190r Label (Doc1)
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