STIMULANT LAXATIVE ENTERIC COATED- bisacodyl tablet 
Geri-Care Pharmaceutical Corp

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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440

Active ingredient (in each tablet)

Bisacodyl 5 mg

Purpose

Stimulant Laxative

Uses

  • relieves occasional constipation and irregularity
  • this product generally produces a bowel movement in 6 to 12 hours

Warnings

Do not use

  • if you cannot swallow without chewing
  • within 1 hour after taking an antacid or milk

Ask a doctor before use if you have

  • abdominal pain
  • nausea
  • vomiting
  • a sudden change in bowel habits that lasts longer than 2 weeks

When using this product

  • abdominal discomfort, faintness, or cramps may occur

Stop use and ask a doctor

  • if you have rectal bleeding or no bowel movement within 12 hours after using this product. These could be signs of a serious condition.
  • if you need a laxative for more than one week

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

  • do not take more than directed
  • swallow whole, do not chew or crush
  • take recommended dose in a single daily dose
  • take with a glass of water
  • adults and children 12 years and older: take 1-3 (usually 2) tablets daily
  • children 12 and under: ask a doctor

Other information

  • each tablet contains: magnesium 5 mg
  • store at room temperature
  • avoid excessive humidity
  • Tamper Evident: Do not use if imprinted seal under cap is missing or broken
  • package not child resistant

Inactive ingredients

acacia, calcium sulfate, cellulose, corn starch, D&C yellow #10 lake, FD&C yellow #6 lake, gelatin, iron oxide, lactose, magnesium
stearate, PEG, polyvinyl acetate phthalate, povidone, shellac, silica, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide, wax.

Package Label

GERICARE

NDC 57896-440-01

Bisacodyl

Stimulant laxative

enteric coated

100 Tablets

5 mg each

440-01

STIMULANT LAXATIVE ENTERIC COATED 
bisacodyl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-440
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)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
STARCH, CORN (UNII: O8232NY3SJ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)  
POVIDONE (UNII: FZ989GH94E)  
SHELLAC (UNII: 46N107B71O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
GELATIN (UNII: 2G86QN327L)  
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize5mm
FlavorImprint Code TCL003
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57896-440-01100 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2017
2NDC:57896-440-101000 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33403/01/201701/01/2019
Labeler - Geri-Care Pharmaceutical Corp (611196254)
Registrant - Geri-Care Pharmaceutical Corp (611196254)

Revised: 12/2020
 
Geri-Care Pharmaceutical Corp