Assured 44-676-Delisted

Drug Labeling and Warnings

Drug Details [pdf]

GENTLE LAXATIVE- bisacodyl tablet, coated 
GREENBRIER INTERNATIONAL, 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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Assured 44-676-Delisted

Active ingredient (in each tablet)

Bisacodyl 5 mg

Purpose

Stimulant laxative

Uses

  • for relief of occasional constipation (irregularity)
  • this product generally produces bowel movement in 6 to 12 hours

Warnings

Do not use

if you are unable to swallow without chewing.

Ask a doctor before use if you have

  • abdominal pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that persists over a period of 2 weeks

When using this product

  • abdominal discomfort, faintness, and cramps may occur
  • do not use for a period longer than 1 week unless directed by a doctor

Stop use and ask a doctor if

rectal bleeding or failure to have a bowel movement occurs after use of a laxative. These may be signs of 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 (1-800-222-1222) right away.

Directions

  • do not chew or crush tablets
  • do not take within 1 hour after taking an antacid or milk
  • take with water
  • adults and children 12 years and over: take 1 to 3 tablets in a single dose, once daily
  • children under 12 years: ask a doctor

Other information

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • use by expiration date on package

Inactive ingredients

anhydrous lactose, carmine, colloidal silicon dioxide, corn starch, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, methacrylic acid, polydextrose, polyethylene glycol, shellac wax, simethicone, sodium bicarbonate, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate

Questions or comments?

​1-800-426-9391

Principal display panel

COMPARE TO  ACTIVE INGREDIENT OF CORRECTOL®*

ASSURED™

Women's
Gentle Laxative

Bisacodyl 5 mg

Stimulant Laxative

Gentle, dependable
overnight relief

60 enteric coated tablets

*This product is not manufactured or distributed by Bayer Healthcare LLC, owner of the registered trademark Correctol®.
50844  ORG051567611
Item # 229926
Distributed by GREENBRIER INTERNATIONAL, INC.
500 VOLVO PARKWAY, CHESAPEAKE, VA 23320
Assured 44-676

Assured 44-676

GENTLE LAXATIVE 
bisacodyl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 33992-0676
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (UNII: 10X0709Y6I) (BISACODYL - UNII:10X0709Y6I) BISACODYL5 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
STARCH, CORN (UNII: O8232NY3SJ)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHACRYLIC ACID (UNII: 1CS02G8656)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize7mm
FlavorImprint Code B
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 33992-0676-160 in 1 BOTTLE; Type 0: Not a Combination Product09/16/201507/08/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33409/16/201507/08/2019
Labeler - GREENBRIER INTERNATIONAL, INC. (610322518)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(33992-0676)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(33992-0676)

Revised: 8/2016
Document Id: 17cfab46-7dd3-4bf3-8ef5-b6a1865d1b95
Set id: ebf4c894-889c-44bc-b363-c015eceea2f0
Version: 3
Effective Time: 20160815