STOOL SOFTENER PLUS STIMULANT LAXATIVE- docusate sodium and 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.

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Drug Facts

Active ingredients (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

Purpose

Stool softener

Stimulant laxative

Uses

Warnings

Do not use

  • laxative products for longer than 1 week unless directed by a doctor
  • if you are presently taking mineral oil, 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 lasts 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 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

adults and children 12 years and oldertake 2-4 tablets daily 
children 6 to under 12 years of agetake 1-2 tablets daily 
children 2 to under 6 years of age take up to 1 tablet daily 
children under 2 ask a doctor 

Other information

Inactive ingredients

carnauba wax*, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake,  hypromellose, magnesium stearate, maltodextrin*, microcrystalline cellulose, polyethylene glycol*, polyvinyl alcohol*, silcon dioxide, sodium benzoate*, stearic acid, talc*, titanium dioxide

*contains one or more of these ingredients

Questions or comments?

Call toll free 1-888-423-0139

Principal Display Panel

COMPARE TO COLACE® 2-IN-1 ACTIVE INGREDIENT†

Stool Softener

Plus Stimulant Laxative

DOCUSATE SODIUM 50 mg STOOL SOFTENER

SENNOSIDES 8.6 mg STIMULANT LAXATIVE

For Overnight Relief Of Occasional Constipation

TABLETS

GLUTEN FREE

†This product is not manufactured or distributed by Purdue Products L.P., distributor of Colace® 2-IN-1

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY: TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

topcare@topco.comwww.topcarebrand.com

Product Label

Docusate sodium 50 mg, Sennosides 8.6 mg

TOPCARE HEALTH Stool Softener + Stimulant Laxative

STOOL SOFTENER  PLUS STIMULANT LAXATIVE
docusate sodium and sennosides tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-084
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)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
Product Characteristics
ColorredScoreno score
ShapeROUNDSize10mm
FlavorImprint Code TCL097;0806;AV;S44
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-084-011 in 1 BOX01/31/2016
1100 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 finalpart33401/31/2016
Labeler - TOP CARE (Topco Associates LLC) (006935977)

Revised: 11/2022
Document Id: 8ca820a9-429c-4059-8855-9ccd2b9cc8f7
Set id: 3b184800-649b-45d0-9586-8055d6d7fe08
Version: 4
Effective Time: 20221128
 
TOP CARE (Topco Associates LLC)