ENTERIC COATED STIMULANT LAXATIVE- bisacodyl tablet, delayed release 
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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DRUG FACTS

Active ingredient (in each tablet)

Bisacodyl 5 mg

Purpose

Laxative

Uses


  • relieves occasional constipation
  • generally produces bowel movement in 6-12 hours

Warnings

Do not use


  • for longer than one week
  • when abdominal pain, nausea or vomiting are present
  • in children under 6 years of age
  • in persons who cannot swallow without chewing

Ask a doctor before use if you have

noticed a sudden change in bowel habits that lasts over two weeks

Ask a doctor or pharmacist before use if you are

taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

When using this product


  • do not take dose within one hour of taking an antacid or milk
  • you may experience abdominal discomfort, faintness and cramps

Stop use and ask a doctor if

  • you have rectal bleeding
  • you fail to have a bowel movement after use of this product
  • These may indicate a serious condition.

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 CHEW TABLETS

adults and children 12 years and over: 1-3 tablets once daily

children 6 to 11 years: 1 tablet once daily

children under 6 years: ask a doctor

Other information

store at 20°-25°C (68°-77°F)

Inactive ingredients

acacia, anhydrous calcium sulfate, anhydrous lactose, carnauba wax, colloidal silicon dioxide, corn starch, D-C yellow #10 aluminum lake, FD-C yellow #6 aluminum lake, gelatin, iron oxide, iron oxide black, iron oxide yellow (iron oxide ochre), magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide

Questions or comments?

1-800-645-2158

9 am - 5 pm ET, Monday - Friday

DRUG: Enteric Coated Stimulant Laxative

GENERIC: Bisacodyl

DOSAGE: TABLET, DELAYED RELEASE

ADMINSTRATION: ORAL

NDC: 24236-464-02

COLOR: orange

SHAPE: ROUND

SCORE: No score

SIZE: 6 mm

IMPRINT: TCL;003

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • BISACODYL 5mg in 1

INACTIVE INGREDIENT(S):

  • ACACIA
  • POLYVINYL ACETATE PHTHALATE
  • POLYETHYLENE GLYCOL 400
  • CELLULOSE, MICROCRYSTALLINE
  • POVIDONE
  • MAGNESIUM STEARATE
  • SHELLAC
  • TALC
  • SODIUM STARCH GLYCOLATE TYPE A POTATO
  • STEARIC ACID
  • SUCROSE
  • FERRIC OXIDE YELLOW
  • ANHYDROUS LACTOSE
  • CARNAUBA WAX
  • FERROSOFERRIC OXIDE
  • CALCIUM SULFATE ANHYDROUS
  • SILICON DIOXIDE
  • STARCH, CORN
  • D&C YELLOW NO. 10
  • FERRIC OXIDE RED
  • GELATIN
  • FD&C YELLOW NO. 6
  • TITANIUM DIOXIDE

Remedy_Label

ENTERIC COATED STIMULANT LAXATIVE 
bisacodyl tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24236-464(NDC:0536-3381)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL5 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)  
POVIDONE (UNII: FZ989GH94E)  
SHELLAC (UNII: 46N107B71O)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ACACIA (UNII: 5C5403N26O)  
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize6mm
FlavorImprint Code TCL;003
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24236-464-0230 in 1 BLISTER PACK; Type 0: Not a Combination Product08/01/200705/25/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33408/01/200705/25/2018
Labeler - REMEDYREPACK INC. (829572556)

Revised: 10/2018
 
REMEDYREPACK INC.