Active Ingredients (In Each Tablet)
Docusate Sodium 50 mg
Sennosides 8.6 mg
Stool Softener Plus Laxative
FDA Label NDC 63868-137
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Quality Choice (chain Drug Marketing Association) for the product Stool Softener Plus Laxative (NDC 63868-137). 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 ingredients (in each tablet), purpose, uses, do not use, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breastfeeding,, 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
Purpose
Stool softener
Laxative
Stool softener
laxative
Uses
- relieves occasional constipation (irregularity)
- generally causes 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.
Stop Use And Ask A Doctor If
- you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.
If Pregnant Or Breastfeeding,
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
age | starting dosage | maximum dosage |
| 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 tablet twice a day |
| children under 2 years | ask a doctor | ask a doctor |
Other Information
- each tablet contains: calcium 20 mg
- each tablet contains: sodium 6 mg VERY LOW SODIUM
- store at 25°C (77°); excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients
carnauba wax, croscarmellose sodium, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue #2 aluminum lake*, FD&C red #40 aluminum lake*, FD&C yellow #6 aluminum lake, hypromellose*, magnesium stearate, maltodextrin*, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol*, silicon dioxide, sodium benzoate, stearic acid, talc* and titanium dioxide.
*contains one or more of these ingredients
Questions Or Comments?
call 1-248-449-9300 Monday-Friday 9AM-5PM EST
Principal Display Panel
†Compare to the active ingredients in Senokot-S®
Stool Softener plus laxative
Stool Softener • Laxative
Docusate Sodium, 50 mg/ Sennosides, 8.6 mg
Provides Gentle Relief of: Occasional Constipation
Tablets
†This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Senokot-S®
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP ID BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Distributed by C.D.M.A., Inc©
43157 W. Nine Mile
Novi, MI 48376-0995
Product Label
Quality Choice Stool Softener Orange Tablets
* Please review the disclaimer below.
