Your browser does not support JavaScript! LEADER STOOL SOFTENER PLUS STIMULANT LAXATIVE (DOCUSATE SODIUM, SENNOSIDES) TABLET [CARDINAL HEALTH]
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RxNorm Names

LEADER STOOL SOFTENER PLUS STIMULANT LAXATIVE (docusate sodium, sennosides) tablet
[Cardinal Health]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Label Sections

Active Ingredients (in each tablet)

Docusate Sodium 50mg
Sennosides 8.6mg

Purpose

Stool softener
Stimulant Laxative

Uses

  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement within 6 to 12hours.

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 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 immediately.

Directions

Take only by mouth. Doses may be taken as a single daily does 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 tablet daily
  • children under 2: ask a doctor

Other information

  • each softgel contains: sodium 6mg VERY LOW SODIUM
  • each tablet contains: calcium 20mg/tablets
  • store at 15 - 30 degrees C (59-86 degrees F), protect from excessive moisture
  • do not use if imprinted safety seal under cap is broken or missing.
  • *This product is not manufactured or distributed by Purdue Products, LP, owner of the registered trademark Peri Colace.

Inactive Ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, ethanol, FDandC Blue no2 Aluminum Lake, FDandC Red No40 Aluminum Lake, hypromellose, magnesium stearate, *maltodextrin, microcrystalline cellulose, *mineral oil, *Opadry II red, polyethylene glycol (PEG) 400, *pregelatinized starch, *silicon dioxide 50s, sodium benzoate, stearic acid and titanium dioxide. *May also contain.

Questions or comments?

call toll free:1-800-200-6313

Comapre to the active ingredient Peri Colace               

Leader

Stool Softener plus Stimulant Laxative

Docusate Sodium 50mg
Sennosides, 8.6mg

Relieves of Occasional Constipation
100 Softgels

Distributed by Cardinal Health
Dublin, Ohio 43017
CIN 1382639

www.myleader.com
1-800-200-6313

All Leader Brand Products are 100% satisfaction guaranteed or return to place of purchase for a full refund.

Product Labeling

Stool Softener

LEADER STOOL SOFTENER PLUS STIMULANT LAXATIVE 
docusate sodium, sennosides tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:37205-349
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM50 mg
SENNOSIDES A AND B (SENNOSIDES A AND B) SENNOSIDES A AND B8.6 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE 
ALCOHOL 
FD&C BLUE NO. 2 
FD&C RED NO. 40 
HYPROMELLOSES 
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
MINERAL OIL 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 400 
SODIUM BENZOATE 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
Colorred (RED) Scoreno score
ShapeROUND (ROUND) Size10mm
FlavorImprint Code TLC97;SS1;S44
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-349-78100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33403/01/2012
Labeler - Cardinal Health (097537435)

Revised: 3/2012
 
Cardinal Health

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