Otc - Active Ingredient
Active ingredients (in each tablet)
Docusate sodium 50 mg
Sennosides 8.6 mg
Senexon-s
FDA Label NDC 52959-675
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by H.j. Harkins Company, Inc. for the product Senexon-s (NDC 52959-675). 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, otc - ask doctor/pharmacist, warnings, otc - keep out of reach of children, 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
ASK A DOCTOR BEFORE USE IF YOU HAVE A SUDDEN CHANGE IN BOWEL HABITS THAT LASTS OVER TWO WEEKS
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist berfore use if you are taking any other drug. Laxatives may affect how other drugs work.
Warnings
Do not use if your are taking mineral oil; for longer than one week; when abdominal pain, nausea or vomiting are present
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 - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Purpose
Uses: relieves occasional constipation; generally produces bowel movement in 6-12 hours.
Otc - Questions
call 1 800 645-2158 9 am - 5 pm Monday - Friday
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.
Inactive Ingredient
Inactive ingredients
carnauba wax, colloidal silicon dioxide, croscarmellose sodium
D-C yellow #10 aluminum lake, dibasic calcium phosphate
dihydrate, FD-C yellow #6 aluminum lake, hypromellose,
magnesium stearate, microcrystalline cellulose, polyethylene
glycol, sodium benzoate, stearic acide, Titanium dioxide
Otc - When Using
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 maxiumum dosage)
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
children under 2 years - ask a doctor
Indications & Usage
RELIEVES OCCASIONAL CONSTIPATION
GENERALLY PRODUCES BOWEL MOVEMENT IN 6-12 HOURS
Package Label.Principal Display Panel
Label (Label)
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