STIMULANT LAXATIVE ENTERIC COATED- bisacodyl tablet 
Bryant Ranch Prepack

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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441

Active ingredient (in each tablet)

Bisacodyl 5 mg

Purpose

Stimulant Laxative

Uses

  • for 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, vomiting
• noticed a sudden change in bowel habits that lasts more than 2 weeks
When using this product • do not chew or crush tablet(s)
• do not use within 1 hour after taking an antacid or milk
• it may cause stomach discomfort, faintness and cramps
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
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

  • take with a glass of water
  • adults and children 12 years and older: take 1 to 3 tablets in a single daily dose
  • children 12 and under: ask a doctor

Other information

• Tamper Evident: Do not use if imprinted seal under cap is missing or broken
• store at room temperature 15°-30°C (59°-86°F)
• avoid excessive humidity • package not child resistant

Inactive ingredients

acacia, ammonium hydroxide,
calcium carbonate, corn starch, D&C yellow #10 lake,
FD&C yellow #6 lake, hypromellose, iron oxide black, lactose,
magnesium stearate, methylparaben, PEG, polydextrose,
polyvinyl acetate phthalate, propylparaben, propylene glycol,
povidone, shellac, simethicone, silica, sodium alginate,
sodium benzoate, sodium bicarbonate, stearic acid, sucrose,
talc, titanium dioxide, triacetin, triethyl citrate, wax.

Questions or comments?

1-800-540-3765

HOW SUPPLIED

NDC: 71335-1531-0: 25 Tablets in a BOTTLE

NDC: 71335-1531-1: 30 Tablets in a BOTTLE

NDC: 71335-1531-2: 2 Tablets in a BOTTLE

NDC: 71335-1531-3: 3 Tablets in a BOTTLE

NDC: 71335-1531-4: 4 Tablets in a BOTTLE

NDC: 71335-1531-5: 10 Tablets in a BOTTLE

NDC: 71335-1531-6: 90 Tablets in a BOTTLE

NDC: 71335-1531-7: 8 Tablets in a BOTTLE

NDC: 71335-1531-8: 100 Tablets in a BOTTLE

NDC: 71335-1531-9: 20 Tablets in a BOTTLE

Bisacodyl 5mg Tablet

Label
STIMULANT LAXATIVE ENTERIC COATED 
bisacodyl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-1531(NDC:57896-441)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL5 mg
Inactive Ingredients
Ingredient NameStrength
SODIUM ALGINATE (UNII: C269C4G2ZQ)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
ACACIA (UNII: 5C5403N26O)  
AMMONIA (UNII: 5138Q19F1X)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
STARCH, CORN (UNII: O8232NY3SJ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SHELLAC (UNII: 46N107B71O)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize6mm
FlavorImprint Code 5
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71335-1531-025 in 1 BOTTLE; Type 0: Not a Combination Product03/10/2022
2NDC:71335-1531-130 in 1 BOTTLE; Type 0: Not a Combination Product05/14/2020
3NDC:71335-1531-22 in 1 BOTTLE; Type 0: Not a Combination Product03/10/2022
4NDC:71335-1531-33 in 1 BOTTLE; Type 0: Not a Combination Product03/10/2022
5NDC:71335-1531-44 in 1 BOTTLE; Type 0: Not a Combination Product03/09/2020
6NDC:71335-1531-510 in 1 BOTTLE; Type 0: Not a Combination Product06/16/2020
7NDC:71335-1531-690 in 1 BOTTLE; Type 0: Not a Combination Product03/10/2022
8NDC:71335-1531-78 in 1 BOTTLE; Type 0: Not a Combination Product03/10/2022
9NDC:71335-1531-8100 in 1 BOTTLE; Type 0: Not a Combination Product03/10/2022
10NDC:71335-1531-920 in 1 BOTTLE; Type 0: Not a Combination Product03/10/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33401/01/2000
Labeler - Bryant Ranch Prepack (171714327)
Registrant - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(71335-1531) , RELABEL(71335-1531)

Revised: 3/2022
 
Bryant Ranch Prepack