Otc - Active Ingredient
Docusate sodium 50 mg, Sennoside 8.6 mg.
Senna And Docusate Sodium
FDA Label NDC 11534-134
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sunrise Pharmaceutical Inc for the product Senna And Docusate Sodium (NDC 11534-134). 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 and 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
Stimulant laxative.
Indications And Usage
For temporary relief of occasional constipation and irregularity.
This product generally produces bowel movement in 6 to 12 hours.
Warnings
Do not use:
laxative products for longer than 1 week unless told to do so by a doctor.
if you are presently taking mineral oil, unless told to do so by a doctor
Otc - Ask Doctor
Before use if you have:
Stomach pain, nausea or vomiting
Noticed a sudden change in bowel habits that lasts over 2 weeks.
Otc - Stop Use
If you have rectal bleeding or fail to have bowel movement after use of a laxative. This could be a serious condition.
Otc - Pregnancy Or Breast Feeding
Ask a health professional before use.
Otc - Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center right away.
Dosage And Administration
Drink with a full glass of water with each dose
| Adults and children 12 years and over | take 2 - 4 tablets daily |
| Children 6 to under 12 years | take 1 - 2 tablets daily |
| Children 2 to under 6 years | take up to 1 tablet daily |
| Children under 2 years of age | Ask a doctor |
OTHER INFORMATION
Each tablet contains: calcium 30 mg, sodium 3 mg VERY LOW SODIUM.
Do not use if the imprinted safety seal under cap is missing or damaged.
Store at at 25°C (77°F); excursions permitted between 15(-30(C (59(-86(F)
Keep tightly closed.
Inactive Ingredient
Colloidal silicon dioxide, dicalcium phosphate, ethanol, FD&C blue #2, FD&C red #40, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, pregelatinized starch, silicon dioxide, sodium benzoate, stearic acid, titanium dioxide.
* Please review the disclaimer below.
