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Gentle Laxative by Harmon Store Inc.

Medically reviewed on Jan 22, 2018

Dosage form: tablet, coated
Ingredients: BISACODYL 5mg
Labeler: Harmon Store Inc.
NDC Code: 63940-327

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.

Core Values 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 use within 1 hour after taking an antacid or milk
  • do not chew or crush tablet(s)
  • 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 overtake 1 to 3 tablets in a single daily dose
children 6 to under 12 yearstake 1 tablet in a single daily dose
children under 6 yearsask a doctor

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

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

CORE VALUES™

Compare to active ingredient
in Dulcolax® Laxative

NDC 63940-327-56

Gentle Laxative

Bisacodyl USP, 5 mg
Stimulant Laxative

predictable overnight relief

Actual Size

25 coated 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.
50844        REV0217A32756

Distributed by: Liberty Procurement, Inc.,
650 Liberty Ave., Union, NJ 07083 U.S.A.
Satisfaction Guaranteed Or Your Money Back Visit us at www.facevalues.com

Core Values 44-327

GENTLE LAXATIVE 
bisacodyl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-327
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 
ANHYDROUS LACTOSE 
MAGNESIUM STEARATE 
METHYLPARABEN 
POLYDEXTROSE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
Polyvinyl Acetate Phthalate 
POVIDONE, UNSPECIFIED 
PROPYLENE GLYCOL 
PROPYLPARABEN 
SHELLAC 
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:63940-327-561 BLISTER PACK in 1 CARTON
125 TABLET, COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33403/25/2002
Labeler - Harmon Store Inc. (804085293)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(63940-327)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(63940-327)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(63940-327)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(63940-327)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(63940-327)

 
Harmon Store Inc.

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Further information

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

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