SENNA S- docusate sodium, sennosides tablet 
TOP CARE (Topco Associates LLC)

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Drug Facts

Active ingredients (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

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
 agestarting dosage maximum dosage 
adults and children 12 years of age and over2 tablets once a day4 tablets twice a day 
children 6 to under 12 years1 tablet once a day2 tablets twice a day 
children 2 to under 6 years1/2 tablet once a day 1 tablet twice a day 
children under 2 yearsask a doctor ask a doctor 

Other information

  • each tablet contains: calcium 20 mg
  • each tablet contains: sodium 6 mg LOW SODIUM
  • store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)

Inactive ingredients

carnauba wax, croscarmellose sodium, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate,FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, sodium benzoate, stearic acid,  titanium dioxide


Questions or comments?

Call toll free 1-888-423-0139

Principal Display Panel

COMPARE TO SENOKOT-S® ACTIVE INGREDIENTS†

Vegetable Laxative

+ Stool Softener

DOCUSATE SODIUM 50 mg • STOOL SOFTENER

SENNOSIDES 8.6 MG • LAXATIVE

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 TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

topcare@topco.com

www.topcarebrand.com

Product Labeling

Docusate Sodium 50 mg, Sennosides 8.6 mg

TOP CARE HEALTH Stool Softener Vegetable Laxative

SENNA S 
docusate sodium, sennosides tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-776
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize10mm
FlavorImprint Code TCL081
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-776-601 in 1 BOX07/31/201912/29/2023
160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:36800-776-121 in 1 BOX07/31/201912/29/2023
2120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33407/31/201912/29/2023
Labeler - TOP CARE (Topco Associates LLC) (006935977)

Revised: 4/2022
 
TOP CARE (Topco Associates LLC)