Active Ingredients (In Each Tablet)
Docusate sodium 50 mg
Sennosides 8.6 mg
Sool Softener Laxative Tablet
FDA Label NDC 49035-270
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Equate (wal-mart Stores, Inc.) (see Also Wal-mart Inc) for the product Sool Softener Laxative (NDC 49035-270). 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 breast-feeding,, 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
Uses
- 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
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 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
| age | starting dosage | maximum dosage |
| adults and children 12 years of age or over | 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°F); 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 red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, sodium benzoate* stearic acid, talc, titanium dioxide
Questions Or Comments?
Call 1-888-287-1915
Principal Display Panel
†Compare to the active ingredient in Senokot-S®
DUAL ACTION
Natural Vegetable
Laxative + Stool Softener
Docusate sodium, 50 mg
Stool softener
Sennosides, 8.6 mg
Laxative
- Effective, Comfortable
- Overnight relief
- Gentle, dependable
TABLETS
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
†This product is not manufactured or distributed by Avrio Health L.P., distributor of Senokot-S®.
DISTRIBUTED BY: Wal-Mart Inc.,
Bentonville, AR 72716
Product Labeling
EQUATE Senna S Stool Softener Laxative
* Please review the disclaimer below.
