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Gentle Laxative by Wal-Mart Stores Inc

Dosage form: tablet, sugar coated
Ingredients: BISACODYL 5mg
Labeler: Wal-Mart Stores Inc
NDC Code: 49035-327

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.

Equate 44-327

Active ingredient (in each tablet)

Bisacodyl 5 mg

Purpose

Stimulant laxative

Uses
  • relieves 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 or 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 overtake 1 to 3 tablets in a single daily dose
 children 6 to under 12 years of agetake 1 tablet in a single daily dose
 children under 6 years of age ask a doctor



Other information
  • store at 25ºC (77ºF), excursions permitted between 15°-30°C (59°-86°F)
  • avoid excessive humidity
  • use by expiration date on package

Inactive ingredients

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

Principal Display Panel

NDC 49035-327-12

equate®

Compare to Dulcolax® Laxative Active ingredient*

Gentle
Laxative
Bisacodyl Delayed-Release
Tablets, USP

Gentle, Predictable Overnight Relief

5   
mg  

 100 
COMFORT 
COATED 
TABLETS

Actual size

Distributed by: Wal-Mart Stores, Inc., Bentonville,
AR 72716 ©Wal-Mart Stores, Inc.
* This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc., owner of the registered trademark Dulcolax® .
50844        REV0312B32712

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Equate 44-327


GENTLE LAXATIVE 
bisacodyl tablet, sugar coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-327
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 
HYPROMELLOSE, UNSPECIFIED 
FERROSOFERRIC OXIDE 
MAGNESIUM STEARATE 
METHYLPARABEN 
POLYDEXTROSE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POVIDONE 
PROPYLENE GLYCOL 
PROPYLPARABEN 
SHELLAC 
DIMETHICONE 
SODIUM ALGINATE 
SODIUM BENZOATE 
SODIUM BICARBONATE 
STEARIC ACID 
SUCROSE 
TALC 
TITANIUM DIOXIDE 
TRIACETIN 
TRIETHYL CITRATE 
LACTOSE, UNSPECIFIED FORM 
Polyvinyl Acetate Phthalate 
SILICON DIOXIDE 
WATER 
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize6mm
FlavorImprint Code5
Contains    
Packaging
#Item CodePackage Description
1NDC:49035-327-191 BLISTER PACK in 1 CARTON
18 TABLET, SUGAR COATED in 1 BLISTER PACK
2NDC:49035-327-12100 TABLET, SUGAR COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33403/25/2002
Labeler - Wal-Mart Stores Inc (051957769)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(49035-327)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(49035-327)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(49035-327)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(49035-327)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(49035-327)

 
Wal-Mart Stores Inc

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Medically reviewed on Sep 19, 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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