Otc - Active Ingredient
Active ingredient (in each tablet) Sennosides 8.6mg
Senexon
FDA Label NDC 45865-483
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Medsource Pharmaceuticals for the product Senexon (NDC 45865-483). 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 - ask doctor/pharmacist, otc - ask doctor, warnings, otc - stop use, otc - pregnancy or breast feeding, otc - purpose, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking any other drug. Take this product tow or more hours before or after other drugs. Laxatives may affect how other drugs work.
Otc - Ask Doctor
Ask a doctor before use if you have noticed a sudden change in bowel habits that lasts over two weeks.
Warnings
Do not use for longer than one week, when abdominal pain, nausea or vomiting are present.
Otc - Stop Use
Stop use and ask a doctor if: you have rectal bleeding; you fail to have a bowel movement after use of this product. These may indicate a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Purpose
uses
relieves occasional constipation(irregularity);generally causes bowel movement in 6-12 hours.
Otc - Questions
1800 645-2158 9 am - 5 pm Monday - Friday
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.
Inactive Ingredient
Inactive Ingredients croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, minerol oil
Dosage & Administration
Dosage and Administration
Adults and children 12 years and over - 2 tablets once a day - maximum dosage - 4 tablets twice a day
Children 6 to under 12 years - 1 tablet once a day maximum dosage - 2 tablets twice a day
children 2 to under 6 years - 1/2 tablet once a day - maximum dosage - 1 tablet twice a day
Indications & Usage
Relieves occasional constipation
Generally produces bowel movement in 6-12 hours
Package Label.Principal Display Panel
Pdp (483)
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