Bisacodyl

Bisacodyl

Drug Labeling and Warnings

Drug Details

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BISACODYL- bisacodyl tablet 
Spirit Pharmaceuticals LLC

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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Bisacodyl

Drug Facts

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

Ifpregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

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

Compare to the active ingredient
in Dulcolax®†

GENTLE
LAXATIVE

Bisacodyl Tablets,
USP 5 mg

gentle
overnight relief

25 tablets

†This product is not manufactured or distributed by
Boehringer Ingelheim Pharmaceuticals, Inc., owner of the
registered trademark Dulcolax®

image description

BISACODYL 
bisacodyl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 68210-3120
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)  
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
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)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)  
POVIDONE K30 (UNII: U725QWY32X)  
SHELLAC (UNII: 46N107B71O)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize5mm
FlavorImprint Code TCL003
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 68210-3120-21 in 1 CARTON03/11/2020
125 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33403/11/2020
Labeler - Spirit Pharmaceuticals LLC (179621011)
Establishment
NameAddressID/FEIBusiness Operations
Time Cap Laboratories, Inc.037052099manufacture(68210-3120)

Revised: 3/2020
 
Spirit Pharmaceuticals LLC


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