BISACODYL ENTERIC- bisacodyl enteric tablet, coated 
DIRECT RX

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BISACODYL

Bisacodyl 5mg

Do not use

Do not use if you cannot swallow without chewing

Ask a doctor before use if

-you have a sudden change in bowel habits that lasts more than 2 weeks

-stomach pain, nausea or vomiting

When using this product

-do not use within 1 hour after taking an antacid or milk

-do not chew or crush tablet(s)

-you may have stomach discomfort, faintness or cramps

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.

-you need to use a laxative for more than 1 week

Pregnancy/Breastfeeding

ask a health professions before use.

Keep out of reach of children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Stimulant laxative

-relieves occasional constipation and irregularity

-this product generally produces bowel movement in 6 to 12 hours

-take with a glass of water

adults and children 12 years and over- take 1 to 3 tablets in a single daily dose

children 6 to under 12 years of age - take 1 tablet in a single daily dose

children under 6 years of age - ask a doctor

-store at 25 degrees C (77 degrees F) excursions permitted between 15 degrees-30 degrees C (59 degrees-86 degrees F)

-use by expiration date on package

-protect from excessive humidity


acacia, bees wax, calcium sulfate, carnauba wax, cellulose, corn starch, D&C Yellow No. 10 lake, FD&C Yellow No. 6 lake, gelatin, lactose, magnesium stearate, pharmaceutical glaze, polyvinyl acetate phthalate, silica gel, sodium starch glycolate, stearinc acid, sugar, talc, titanium dioxide.

085

BISACODYL ENTERIC 
bisacodyl enteric tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61919-085(NDC:0904-7927)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL5 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
AMMONIUM NONOXYNOL-4 SULFATE (UNII: 9HIA70O4J0)  
SHELLAC (UNII: 46N107B71O)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
ACACIA (UNII: 5C5403N26O)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
STARCH, CORN (UNII: O8232NY3SJ)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize6mm
FlavorImprint Code 5
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61919-085-6060 in 1 BOTTLE; Type 0: Not a Combination Product02/24/201710/06/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00702/24/201710/06/2023
Labeler - DIRECT RX (079254320)
Registrant - DIRECT RX (079254320)
Establishment
NameAddressID/FEIBusiness Operations
DIRECT RX079254320repack(61919-085)

Revised: 10/2023
 
DIRECT RX