FLEET- bisacodyl tablet 
C.B. Fleet Company, Inc.

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 Ingredient (in each tablet)

Bisacodyl 5 mg, Stimulant Laxative

Use

For relief of occasional constipation.

Warnings

May cause abdominal discomfort, faintness and cramps.

Swallow tablets whole. It is important that you do not chew or crush. Do not give to children under 6 years of age, or to persons who cannot swallow without chewing, unless directed by a doctor.

Do not take within 1 hour after taking an antacid, milk or milk products.

Ask a doctor before using any laxative if you have

  • abdominal pain, nausea or vomiting
  • a sudden change in bowel habits lasting more than 2 weeks
  • already used a laxative for more than 1 week

Stop using this product and consult a doctor if you

  • have rectal bleeding
  • have no bowel movement after use

These symptoms may indicate 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

Single Daily Dosage

adults and children 12 years and over
1 - 3 tablets
children 6 to under 12 years
1 tablet
children under 6 years
ask a doctor

Other Information

  • this product generally produces bowel movement in 6-12 hours
  • each tablet is imprinted with "TCL 0003" for identification
  • store at temperatures not above 86F (30C)
  • do not use if foil imprinted with "Bisacodyl 5mg Laxative Tablet" is broken or missing
  • consult Physicians' Desk Reference for complete professional labeling

Inactive Ingredients

acacia, anhydrous lactose, beeswax, calcium sulfate, carnauba wax, collodial silicon dioxide, corn starch, DandC yellow 10 lake, FDandC yellow 6 lake, gelatin, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, polyvinyl acetate phthalate, povidone, sodium starch glycolate, stearic acid, sucrose, talc, titanium dioxide

Questions?

1-866-255-6960 or www.fleetlabs.com

image of label

FLEET 
bisacodyl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0132-0704
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL5 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA (UNII: 5C5403N26O)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CALCIUM SULFATE (UNII: WAT0DDB505)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SHELLAC (UNII: 46N107B71O)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize24mm
FlavorImprint Code TCL003
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0132-0704-0225 in 1 CARTON; Type 0: Not a Combination Product06/05/200210/31/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33406/05/200210/31/2017
Labeler - C.B. Fleet Company, Inc. (003119054)
Establishment
NameAddressID/FEIBusiness Operations
Time Cap Laboratories, Inc.037052099manufacture(0132-0704)

Revised: 12/2017
 
C.B. Fleet Company, Inc.