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Laxative by GREENBRIER INTERNATIONAL, INC.

Dosage form: tablet, sugar coated
Ingredients: BISACODYL 5mg
Labeler: GREENBRIER INTERNATIONAL, INC.
NDC Code: 33992-0327

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 44-327

Active ingredient (in each tablet)

Bisacodyl USP, 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)
  • do not use within 1 hour after taking an antacid or milk
  • you may have stomach discomfort, faintness and cramps

Stop use and ask a doctor if
  • you have rectal bleeding or fail to have a bowel movement after use of a laxative. 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 (1-800-222-1222) right away.

Directions
  • take with a glass of water

adults and children 12 years and over

 take 1 to 3 tablets in a single daily dose

children 6 to under 12 years

 take 1 tablet in a single daily dose

children under 6 years

 ask a doctor

Other information
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • avoid excessive humidity
  • see end flap for expiration date and lot number
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

Inactive ingredients

acacia, ammonium hydroxide, calcium carbonate, carnauba wax, colloidal anhydrous silica, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, iron oxide black, lactose anhydrous, magnesium stearate, methylparaben, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparaben, shellac glaze, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate

Questions or comments?

1-800-426-9391

Principal display panel

COMPARE TO ACTIVE INGREDIENT IN DULCOLAX® LAXATIVE TABLETS*

ASSURED™

Laxative

• Bisacodyl USP, 5 mg
Stimulant Laxative

Gentle, Predictable,
Overnight Relief

Actual Size
Comfort Coated

25 Tablets

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc., owner of the registered trademark Dulcolax® Laxative Tablets.

50844      ORG021732756

DISTRIBUTED BY:
GREENBRIER INTERNATIONAL, INC.
500 VOLVO PARKWAY,
CHESAPEAKE, VA 23320

Assured 44-327


LAXATIVE 
bisacodyl tablet, sugar coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-0327
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (DEACETYLBISACODYL) BISACODYL5 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA 
AMMONIA 
CALCIUM CARBONATE 
CARNAUBA WAX 
STARCH, CORN 
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
HYPROMELLOSES 
FERROSOFERRIC OXIDE 
ANHYDROUS LACTOSE 
MAGNESIUM STEARATE 
METHYLPARABEN 
POLYDEXTROSE 
POLYETHYLENE GLYCOLS 
Polyvinyl Acetate Phthalate 
POVIDONE 
PROPYLENE GLYCOL 
PROPYLPARABEN 
SODIUM ALGINATE 
SODIUM BENZOATE 
SODIUM BICARBONATE 
STEARIC ACID 
SUCROSE 
TALC 
TITANIUM DIOXIDE 
TRIACETIN 
TRIETHYL CITRATE 
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize6mm
FlavorImprint Code5
Contains    
Packaging
#Item CodePackage Description
1NDC:33992-0327-61 BLISTER PACK in 1 CARTON
125 TABLET, SUGAR COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33403/25/2002
Labeler - GREENBRIER INTERNATIONAL, INC. (610322518)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(33992-0327)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(33992-0327)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(33992-0327)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(33992-0327)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(33992-0327)

 
GREENBRIER INTERNATIONAL, INC.

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Medically reviewed on Jan 31, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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