Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

STOOL SOFTENER PLUS STIMULANT LAXATIVE- docusate sodium, sennosides tablet 
Cardinal Health (Leader) 49781

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

  • for overnight relief from occasional constipation (irregularity)
  • generally produces a bowel movement within 6 to 12 hours

Warnings

Do not use

  • laxative products for longer than 1 week unless told to do so by a doctor
  • if you are presently taking mineral oil, unless told to do so 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 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

  • Take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses.
 adults and children 12 years and over take 2-4 tablets daily 
 children 6 to under 12 years of age take 1-2 tablets daily
 children 2 to under 6 years of age take up to 1 tablets daily
 children under 2 ask a doctor

Other information

  • each tablet contains: calcium 20 mg
  • each tablet contains: sodium 6 mg VERY LOW SODIUM
  • store at 15º-30ºC (59º-86ºF), protect from excessive moisture

Inactive ingredients

carnauba wax*, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake*, hypromellose, magnesium stearate, maltodextrin*, microcrystalline cellulose, polydextrose*, polyethylene glycol*, purified water*, sodium benzoate*, stearic acid*, talc*, titanium dioxide, triglycerides*

*contains one or more of these ingredients

Questions or comments?

Call 1-800-200-6313 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to Peri-Colace® active ingredients**

Stool Softener

Plus Stimulant Laxative

Docusate sodium, 50 mg

Sennosides, 8.6 mg

For Relief of Occasional Constipation               

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

**This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Peri-Colace®.

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Product Labeling

Docusate Sodium 50 mg, Sennosides 8.6 mg

Leader Stool Softener plus Stimulant Laxative Tablet

STOOL SOFTENER PLUS STIMULANT LAXATIVE 
docusate sodium, sennosides tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 49781-017
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)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CALCIUM PHOSPHATE, DIBASIC, 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 400 (UNII: B697894SGQ)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
WATER (UNII: 059QF0KO0R)  
TALC (UNII: 7SEV7J4R1U)  
C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize10mm
FlavorImprint Code TCL97;SS2;S44
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 49781-017-51100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/201206/30/2019
2NDC: 49781-017-56200 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/201206/30/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33403/01/201206/30/2019
Labeler - Cardinal Health (Leader) 49781 (097537435)
Registrant - P & L Development, LLC (800014821)

Revised: 12/2018
Document Id: dcc2129a-5112-40b9-82af-d3f14130e784
Set id: 977f18e1-aff1-4c4c-bc8a-4181b0ce8beb
Version: 2
Effective Time: 20181219