Otc - Active Ingredient
Active ingredient (in each tablet)
- Docusate sodium 50 mg
- Sennosides 8.6 mg
Senna S
FDA Label NDC 53329-989
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Medline Industries, Lp for the product Senna S (NDC 53329-989). 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 - purpose, indications & usage, warnings, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
- Stool softener laxative
- Stimulant laxative
Indications & Usage
Uses ■ relieves occasional constipation (irregularity)
■ generally produces a 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 - Ask Doctor
Ask a doctor before use if you have
■ stomach pain ■ nausea ■ vomiting
■ a sudden change in bowel movements that persists over
2 weeks
Otc - Stop Use
Stop use and ask a doctor if you have rectal bleeding or fail
to have a bowel movement after use of a laxative. These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health
professional before use.
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.
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.
age | starting dosage | maximum dosage |
adults and children 12 years of age and over | 2 tablets once a day | 4 tablets twice a day |
children 6 to under 12 years | 1 tablet once a day | 2 tablets twice a day |
children 2 to under 6 years | 1/2 tablet once a day | 1 tablet twice a day |
children under 2 years | ask a doctor | ask a doctor |
Other Safety Information
Other information
■
each tablet contains: calcium 20 mg, sodium 6 mg
(VERY LOW SODIUM)
■ store at 25°C (77°F); excursions permitted between
15-30°C (59-86°F)
Inactive Ingredient
Inactive ingredients carnauba wax, colloidal
silicon dioxide, croscarmellose sodium, dibasic
calcium phosphate dihydrate, D&C yellow#10
aluminum lake, FD&C yellow#6 aluminum lake,
hypromellose, magnesium stearate, microcrystalline
cellulose, polyethylene glycol, sodium benzoate,
stearic acid, titanium dioxide
Otc - Questions
Questions or comments?
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