GENTLE LAXATIVE- bisacodyl tablet, delayed release 
Bryant Ranch Prepack

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Sunmark 44-327

Active ingredient (in each tablet)

Bisacodyl USP, 5 mg

Purpose

Stimulant laxative

Uses

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)
  • do not use within 1 hour after taking an antacid or milk
  • you may have stomach discomfort, faintness and 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

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

adults and children 12 years and overtake 1 to 3 tablets in a single daily dose
children 6 to under 12 years
take 1 tablet in a single daily dose
children under 6 yearsask a doctor

Other information

Inactive ingredients

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

Questions or comments?

1-800-426-9391

HOW SUPPLIED

NDC: 71335-1754-0: 25 Tablets in a BLISTER PACK

NDC: 71335-1754-1: 30 Tablets in a BLISTER PACK

NDC: 71335-1754-2: 2 Tablets in a BLISTER PACK

NDC: 71335-1754-3: 3 Tablets in a BLISTER PACK

NDC: 71335-1754-4: 4 Tablets in a BLISTER PACK

NDC: 71335-1754-5: 10 Tablets in a BLISTER PACK

NDC: 71335-1754-6: 90 Tablets in a BLISTER PACK

NDC: 71335-1754-7: 8 Tablets in a BLISTER PACK

NDC: 71335-1754-8: 100 Tablets in a BLISTER PACK

NDC: 71335-1754-9: 20 Tablets in a BLISTER PACK

Bisacodyl 5mg Tablet

Label
GENTLE LAXATIVE 
bisacodyl tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-1754(NDC:49348-032)
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)  
AMMONIA (UNII: 5138Q19F1X)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SHELLAC (UNII: 46N107B71O)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
WATER (UNII: 059QF0KO0R)  
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)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize6mm
FlavorImprint Code 5
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71335-1754-025 in 1 BOTTLE; Type 0: Not a Combination Product02/24/2022
2NDC:71335-1754-130 in 1 BOTTLE; Type 0: Not a Combination Product02/24/2022
3NDC:71335-1754-22 in 1 BOTTLE; Type 0: Not a Combination Product02/24/2022
4NDC:71335-1754-33 in 1 BOTTLE; Type 0: Not a Combination Product02/24/2022
5NDC:71335-1754-44 in 1 BOTTLE; Type 0: Not a Combination Product02/24/2022
6NDC:71335-1754-510 in 1 BOTTLE; Type 0: Not a Combination Product02/24/2022
7NDC:71335-1754-690 in 1 BOTTLE; Type 0: Not a Combination Product02/24/2022
8NDC:71335-1754-78 in 1 BOTTLE; Type 0: Not a Combination Product02/24/2022
9NDC:71335-1754-8100 in 1 BOTTLE; Type 0: Not a Combination Product02/24/2022
10NDC:71335-1754-920 in 1 BOTTLE; Type 0: Not a Combination Product02/24/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug505G(a)(3)03/25/200205/04/2025
Labeler - Bryant Ranch Prepack (171714327)
Registrant - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(71335-1754) , RELABEL(71335-1754)

Revised: 4/2024
Document Id: 12e5e85e-bb89-41c6-ad00-115bd135692b
Set id: 20b705fd-de43-4745-b15f-8ce7e90a37ba
Version: 102
Effective Time: 20240405
 
Bryant Ranch Prepack