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Stool Softener Plus Stimulant Laxative

Dosage form: tablet
Ingredients: DOCUSATE SODIUM 50mg, SENNOSIDES 8.6mg
Labeler: Cardinal Health (Leader) 49781
NDC Code: 49781-017

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

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

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 AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM50 mg
SENNOSIDES (SENNOSIDES) SENNOSIDES8.6 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE 
FD&C RED NO. 40 
HYPROMELLOSES 
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 400 
SODIUM BENZOATE 
STEARIC ACID 
TITANIUM DIOXIDE 
FD&C YELLOW NO. 6 
POLYDEXTROSE 
WATER 
TALC 
C10-18 TRIGLYCERIDES 
ALUMINUM OXIDE 
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize10mm
FlavorImprint CodeTCL97;SS2;S44
Contains    
Packaging
#Item CodePackage Description
1NDC:49781-017-51100 TABLET (100 TABLET) in 1 BOTTLE, PLASTIC
2NDC:49781-017-56200 TABLET (200 TABLET) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33403/01/2012
Labeler - Cardinal Health (Leader) 49781 (097537435)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 06/2013
 
Cardinal Health (Leader) 49781

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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