BISACODYL- bisacodyl tablet, delayed release 
Par Pharmaceutical

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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Bisacodyl Tablets, USP

Active ingredient (in each tablet)

Bisacodyl 5 mg

Purpose

Stimulant laxative

Uses

  • for temporary 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 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)
  • it may cause stomach discomfort, faintness and cramps
  • do not use within 1 hour after taking an antacid or milk

Stop use and ask a doctor if

  • 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 over1 to 3 tablets in a single daily dose
children 6 to under 12 years1 tablet in a single daily dose
children under 6 yearsask a doctor

Other information

  • store at 20°-25°C (68°-77°F)
  • protect from excessive humidity

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

Inactive ingredients

calcium sulfate, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10, edible ink, FD&C yellow #6, gelatin, hypromellose, kaolin, lactose, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, polyethylene glycol, propylene glycol, stearic acid, sucrose, sugar, talc, titanium dioxide, triethyl citrate

Mfg. for:
Qualitest Pharmaceuticals
Huntsville, AL 35811

REV. 01/10

PRINCIPAL DISPLAY PANEL

Bisacodyl Tablets, USP 5 mg 100ct label
BISACODYL 
bisacodyl tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0603-2483
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL5 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM SULFATE (UNII: WAT0DDB505)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
KAOLIN (UNII: 24H4NWX5CO)  
LACTOSE (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize6mm
FlavorImprint Code S1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0603-2483-21100 in 1 BOTTLE; Type 0: Not a Combination Product07/08/200508/31/2017
2NDC:0603-2483-321000 in 1 BOTTLE; Type 0: Not a Combination Product07/08/200509/30/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33407/08/200508/31/2017
Labeler - Par Pharmaceutical (011103059)
Registrant - Sunrise Pharmaceutical Inc (168522378)
Establishment
NameAddressID/FEIBusiness Operations
Sunrise Pharmaceutical Inc.168522378MANUFACTURE(0603-2483)

Revised: 10/2017
 
Par Pharmaceutical