BISACODYL- bisacodyl tablet, coated 
REMEDYREPACK INC.

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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Major 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 yearstake 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?

(800)-616-2471

DRUG: Bisacodyl

GENERIC: Bisacodyl

DOSAGE: TABLET, COATED

ADMINSTRATION: ORAL

NDC: 70518-1864-0

NDC: 70518-1864-1

COLOR: orange

SHAPE: ROUND

SCORE: No score

SIZE: 6 mm

IMPRINT: 5

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

INACTIVE INGREDIENT(S):

Remedy_Label

MM2

BISACODYL 
bisacodyl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-1864(NDC:0904-6748)
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 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)  
AMMONIA (UNII: 5138Q19F1X)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize6mm
FlavorImprint Code 5
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70518-1864-030 in 1 BLISTER PACK; Type 0: Not a Combination Product02/13/2019
2NDC:70518-1864-130 in 1 BLISTER PACK; Type 0: Not a Combination Product05/28/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33402/13/2019
Labeler - REMEDYREPACK INC. (829572556)

Revised: 3/2022
Document Id: da435367-486c-20f5-e053-2a95a90a523a
Set id: f8e9ff6d-9627-41ca-b8ee-c3f3705e6bb9
Version: 6
Effective Time: 20220315
 
REMEDYREPACK INC.