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Gentle Laxative by GREENBRIER INTERNATIONAL, INC.

Dosage form: tablet, coated
Ingredients: BISACODYL 5mg
Labeler: GREENBRIER INTERNATIONAL, INC.
NDC Code: 33992-0676

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.

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?

‚Äč1-800-426-9391

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

GENTLE LAXATIVE 
bisacodyl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-0676
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (BISACODYL) BISACODYL5 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE 
STARCH, CORN 
FD&C RED NO. 40 
HYPROMELLOSES 
MAGNESIUM STEARATE 
METHACRYLIC ACID 
POLYDEXTROSE 
POLYETHYLENE GLYCOLS 
SODIUM BICARBONATE 
SODIUM LAURYL SULFATE 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
TRIACETIN 
TRIETHYL CITRATE 
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize7mm
FlavorImprint CodeB
Contains    
Packaging
#Item CodePackage Description
1NDC:33992-0676-160 TABLET, COATED in 1 BOTTLE
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/FEIOperations
LNK International, Inc.038154464PACK(33992-0676)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(33992-0676)

Revised: 08/2016
 
GREENBRIER INTERNATIONAL, INC.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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