Otc - Active Ingredient Section
Active ingredients (in each tablet)
Docusate Sodium 50 mg
Sennosides 8.6 mg
Docusate Sodium And Senna
FDA Label NDC 61919-518
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Direct Rx for the product Docusate Sodium And Senna (NDC 61919-518). 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 section, otc - purpose section, otc - keep out of reach of children section, indications & usage section, warnings section, otc - do not use section, otc - ask doctor section, otc - ask doctor/pharmacist section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose Section
Purposes
Stool Softener
Stimulant Laxative
Otc - Keep Out Of Reach Of Children Section
KEEP OUT OF REACH OF CHILDREN SECTION
Indications & Usage Section
Uses
- relieves occasional constipation
- generally produces bowel movement in 6-12 hours
Warnings Section
Warnings
Otc - Do Not Use Section
Do not use
- for longer than one week
- if you are taking mineral oil
- when abdominal pain, nausea or vomiting are present
Otc - Ask Doctor Section
Ask a doctor before use if you have noticed a sudden change in bowel habits that lasts over two weeks
Otc - Ask Doctor/Pharmacist Section
Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.
Otc - Stop Use Section
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 Section
If pregnant or breast-feeding, ask a health professional before use.
Close
Dosage & Administration Section
Directions
adults and children 12 years and over: 2-4 tablets once daily or in divided doses
children 6 to under 12 years: 1-2 tablets once daily or in divided doses
children 2 to under 6 years: 1/2-1 tablet once daily or in divided doses
children under 2 years: ask a doctor
Storage And Handling Section
Other information
each tablet contains: calcium 20 mg, sodium 6 mg (LOW SODIUM)
store at 20°-25°C (68°-77°F)
Inactive Ingredient Section
Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD-C blue #2 aluminum lake, FD-C red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG), sodium benzoate, stearic acid, titanium dioxide
Otc - Questions Section
Questions or comments?
call 1-800-645-2158, 9 am - 5 pm ET, Monday - Friday
Package Label.Principal Display Panel
Image Description (Docusatesod518)
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