FDA Label for Bisacodyl

View Indications, Usage & Precautions

Bisacodyl Product Label

The following document was submitted to the FDA by the labeler of this product Spirit Pharmaceuticals Llc. 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.

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Drug Facts

Distributed By

Spirit Pharmaceuticals, LLC

Ronkonkoma, NY 11779


Active Ingredient (In Each Tablet)



Bisacodyl (USP) 5 mg


Purpose



Stimulant laxative


Uses



  • for temporary relief of occasional constipation and irregularity
  • this product generally produces bowel movement in 6 to 12 hours

Warnings



Do not use if you cannot swallow without chewing


Ask A Doctor Before Use If You Have



  • stomach pain, nausea or vomiting
  • a sudden change in bowel habits that lasts more than 2 weeks

When Using This Product



  • do not chew or crush tablet(s)
  • it may cause stomach discomfort, faintness and cramps
  • do not use within 1 hour after taking an antacid or milk

Stop Use And Ask A Doctor If



  • you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
  • you need to use a laxative for more than 1 week

Otc - Pregnancy Or Breast Feeding



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 with a glass of water

 adults and children 12 years and over 1 to 3 tablets in a single daily dose
 children 6 to under 12 years of age    1 tablet in a single daily dose
 children under 6 years of age    ask a doctor


Other Information



  • each tablet contains: magnesium 5 mg
  • store at 20-25°C (68-77°F)
  • protect from excessive humidity

Inactive Ingredients



Acacia, anhydrous calcium sulfate, anhydrous lactose, carnauba wax, colloidal silicon dioxide, corn starch, D&C Yellow#10 Aluminum Lake, FD&C Yellow#6 Aluminum Lake, gelatin, iron oxide, iron oxide black, iron oxide yellow (iron oxide ochre), magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide


Questions Or Comments?



1-888-333-9792


Principal Display Panel - 5 Mg Tablets Bottle



VALUMEDS

Compare to the 

active ingredient

in DULCOLAX®*

Laxative

BISACODYL USP 5 mg

Gentle

Overnight Relief

100 TABLETS


* Please review the disclaimer below.