BISACODYL- bisacodyl tablet, coated 
REMEDYREPACK INC.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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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

  • 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 temperature15°-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?

call 516-341-0666,
8:30 am - 4:30 pm ET, Monday - Friday

DRUG: Bisacodyl

GENERIC: Bisacodyl

DOSAGE: TABLET, COATED

ADMINSTRATION: ORAL

NDC: 70518-2997-0

COLOR: orange

SHAPE: ROUND

SCORE: No score

SIZE: 6 mm

IMPRINT: 5

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • BISACODYL 5mg in 1

INACTIVE INGREDIENT(S):

  • STARCH, CORN
  • SHELLAC
  • POVIDONE
  • PROPYLENE GLYCOL
  • PROPYLPARABEN
  • POLYVINYL ACETATE PHTHALATE
  • POLYETHYLENE GLYCOL, UNSPECIFIED
  • POLYDEXTROSE
  • METHYLPARABEN
  • MAGNESIUM STEARATE
  • LACTOSE MONOHYDRATE
  • FERROSOFERRIC OXIDE
  • HYPROMELLOSES
  • D&C YELLOW NO. 10
  • SODIUM ALGINATE
  • CARNAUBA WAX
  • FD&C YELLOW NO. 6
  • CALCIUM CARBONATE
  • AMMONIA
  • ACACIA
  • TRIETHYL CITRATE
  • TRIACETIN
  • TITANIUM DIOXIDE
  • TALC
  • SUCROSE
  • STEARIC ACID
  • SODIUM BICARBONATE
  • SODIUM BENZOATE
  • DIMETHICONE
  • SILICON DIOXIDE

Remedy_Label

BISACODYL 
bisacodyl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-2997(NDC:69618-058)
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)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
STARCH, CORN (UNII: O8232NY3SJ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
HYPROMELLOSES (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 (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:70518-2997-030 in 1 BLISTER PACK; Type 0: Not a Combination Product01/20/202102/05/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/20/202102/05/2021
Labeler - REMEDYREPACK INC. (829572556)

Revised: 3/2023
Document Id: f6dfcf04-0a81-8c3d-e053-6294a90ad90b
Set id: 39bce7ff-edac-488b-8629-2381c0d0a95e
Version: 2
Effective Time: 20230314
 
REMEDYREPACK INC.