Enteric coated stimulant laxative tablet, delayed release

Otc - active ingredient section

Active ingredient (in each tablet)

Bisacodyl 5 mg


Otc - purpose section

Purpose

Laxative


Indications & usage section

Uses


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

Warnings section

Warnings

Otc - do not use section

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

Otc - ask doctor section

Ask a doctor before use if you havenoticed a sudden change in bowel habits that lasts over two weeks


Otc - ask doctor/pharmacist section

Ask a doctor or pharmacist before use if you aretaking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.


Otc - when using section

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

Otc - stop use section

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.


Otc - pregnancy or breast feeding section

If pregnant or breast-feeding,ask a health professional before use.


Otc - keep out of reach of children section

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.


Dosage & administration section

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



Storage and handling section

Other information

store at 20-25C (68-77F)


Inactive ingredient section

Inactive ingredientsacacia, 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


Otc - questions section

Questions or comments?

call 1-800-645-21589 am - 5 pm ET, Monday - Friday


Ingredients and appearance - Product information

Enteric coated stimulant laxative tablet, delayed release- Bisacodyl

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 63629-3049
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Bisacodyl ( UNII: 10X0709Y6I)( Bisacodyl - UNII: 10X0709Y6I ) 5 mgin 1

Inactive Ingredients

Ingredient Name Code
Acacia ( UNII: 5C5403N26O)
Calcium sulfate anhydrous ( UNII: E934B3V59H)
Anhydrous lactose ( UNII: 3SY5LH9PMK)
Carnauba wax ( UNII: R12CBM0EIZ)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Starch, corn ( UNII: O8232NY3SJ)
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)
Povidones ( 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)

Product Characteristics

Color orange Score 1
Shape ROUND Imprint Code TCL;003
Size 6 mm

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph not final part334 USA

Labeler - Bryant Ranch Prepack( 171714327)

Establishment

Name ID/FEI Business Operations
Bryant Ranch Prepack 171714327 REPACK( 63629-3049), RELABEL( 63629-3049)

Package label.principal display panel

Bisacodyl 5mg Tablet