FDA Label for Stool Softener Plus Stimulant Laxative

View Indications, Usage & Precautions

Stool Softener Plus Stimulant Laxative Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health, 110 Dba Leader. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients (In Each Tablet)



Docusate Sodium 50 mg

Sennosides 8.6 mg


Purpose



Stool softener

Stimulant laxative


Uses



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

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 the use of a laxative.

These could be sings 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 (1-800-222-1222).


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 upto 1 tablet daily

    children under 2 

    ask a doctor


Other Information



  • each tablet contains: calcium 10 mg, sodium 5 mg, Very Low Sodium
  • store at 20-25°C (68-77°F); excursions permitted between 15-30oC (59-86oF)

Inactive Ingredients



croscarmellose sodium, dicalcium phosphate, FD&C Red #40, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium benzoate, talc, titanium dioxide


Questions?



(866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)


Package Label.Principal Display Panel



LEADER TM

NDC 70000-0526-1

Stool Softener +

Stimulant Laxative

Docusate Sodium, 50 mg

Sennosides, 8.6 mg

COMPARE TO

COLACE® 2-IN-1

active ingredients*

100% Money

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100 TABLETS


* Please review the disclaimer below.