Stool Softener And Laxative
FDA Label NDC 68210-4180
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Spirit Pharmaceuticals Llc for the product Stool Softener And Laxative (NDC 68210-4180). 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 drug facts, active ingredient (in each tablet), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Tablet)
Docusate sodium 50 mg
Sennosides 8.6 mg
Purpose
Stool softener
Laxative
Uses
• relieves occasional constipation (irregularity) • generally produces bowel movement in 6–12 hours
Warnings
• relieves occasional constipation (irregularity) • generally produces bowel movement in 6–12 hours
Do Not Use
• if you are now 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 • noticed a sudden change in bowel habits that continues over a period of 2 weeks
Ask A Doctor Or Pharmacist Before Use
if you are if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.
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 • you need to use a stool softener laxative for more than 1 week
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. (1-800-222-1222)
Directions
take preferably at bedtime or as directed by a doctor
| Age | Starting Dosage | Maximum Dosage |
| adults & children 12 years of age & over | 2 tablets once a day | 4 tablets twice a day |
| children 6 to under 12 years of age | 1 tablet once a day | 2 tablets twice a day |
| children 2 to under 6 years | ½ tablet once a day | 1 tablet twice a day |
| children under 2 years | ask a doctor | ask a doctor |
Other Information
• each tablet contains: calcium 20 mg and sodium 6 mg
• store at 25°C (77°F); excursions permitted between 15°–30°C (59°–86°F)
Inactive Ingredients
Colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, D&C Yellow No. 10, FD&C Yellow No. 6, hypromellose, magnesium stearate, microcrystalline cellulose, maltodextrin, polyethylene glycol 400, purified water, sodium benzoate, stearic acid, titanium dioxide
Questions Or Comments?
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