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Gentle Laxative by L.N.K. International, Inc.

Medically reviewed on October 10, 2017

Dosage form: tablet, coated
Ingredients: BISACODYL 5mg
Labeler: L.N.K. International, Inc.
NDC Code: 50844-327

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.

Quality Plus 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
  • a sudden change in bowel habits that lasts more than 2 weeks
  • stomach pain, nausea or vomiting

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 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 of age take 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
  • see end flap for expiration date and lot number

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

Questions or comments?

1-800-426-9391

Principal Display Panel

QUALITY
+ PLUS

NDC 50844-327-15

*Compare to active ingredient in Dulcolax® Laxative Tablets

GENTLE
LAXATIVE
Bisacodyl 5 mg
STIMULANT LAXATIVE

Gentle, predictable overnight relief

50 Tablets     COMFORT COATED     ACTUAL SIZE

TAMPER EVIDENT: DO NOT USE IF CARTON 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    ORG031232715

Distributed by
LNK INTERNATIONAL, INC.
60 Arkay Drive
Hauppauge, NY 11788
USA

Quality Plus 44-327

GENTLE LAXATIVE 
bisacodyl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50844-327
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (DEACETYLBISACODYL) BISACODYL5 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA 
CALCIUM CARBONATE 
CARNAUBA WAX 
STARCH, CORN 
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
HYPROMELLOSES 
LACTOSE 
MAGNESIUM STEARATE 
METHYLPARABEN 
POLYDEXTROSE 
POLYETHYLENE GLYCOLS 
Polyvinyl Acetate Phthalate 
POVIDONE 
PROPYLENE GLYCOL 
PROPYLPARABEN 
SHELLAC 
SODIUM ALGINATE 
SODIUM BENZOATE 
SODIUM BICARBONATE 
STEARIC ACID 
SUCROSE 
TALC 
TITANIUM DIOXIDE 
TRIACETIN 
TRIETHYL CITRATE 
FERROSOFERRIC OXIDE 
SILICON DIOXIDE 
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize6mm
FlavorImprint Code5
Contains    
Packaging
#Item CodePackage Description
1NDC:50844-327-152 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 - L.N.K. International, Inc. (038154464)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(50844-327)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(50844-327)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(50844-327)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(50844-327)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(50844-327)

 
L.N.K. 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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