Active Ingredient
Docusate Sodium 50mg
Sennosides 8.6 mg
Sennosides And Docusate Sodium
FDA Label NDC 63739-432
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Mckesson Packaging Services A Business Unit Of Mckesson Corporation for the product Sennosides And Docusate Sodium (NDC 63739-432). 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 active ingredient, purpose, uses, do not use, ask a doctor before use if you have, stop use and ask a doctor if, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Docusate Sodium...............Stool Softener
Sennosides.........................Stimulant Laxative
Uses
- relieves occasional constipation (irregularity)
- generally causes bowel movement in 6-12 hours
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
Ask A Doctor Before Use If You Have
- stomach pain
- nausea
- vomiting
- a sudden change in bowel movements that persists over 2 weeks
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.
- If pregnant or breast -feeding, ask a health professional before use.
- Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away
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 the maximum dosage) or decrease dose until you are comfortable.
| Age | Starting Dose | Maximum Dose |
| Adults and children 12 years of age and older | 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 tablets twice a day |
| Children under 2 years | ask a doctor | ask a doctor |
Other Information
- each tablet contains calcium 20mg, sodium 6mg (LOW SODIUM)
- store at 25°C (77°F)
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, **tapioca starch, **tartaric acid
** may contain one or more of these ingredients
* Please review the disclaimer below.
