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

Medically reviewed on April 21, 2017

Dosage form: tablet, sugar coated
Ingredients: BISACODYL 5mg
Labeler: L.N.K. International, Inc.
NDC Code: 50844-607

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 44-607

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 or cramps

Stop use and ask a doctor if
  • you have rectal bleeding or fail to have a bowel moment 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 15º-30ºC (59º-86ºF)
  • 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 red #27 aluminum lake, FD&C blue #2 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 50844-607-56

*Compare to the active ingredient
in Dulcolax® Pink™

Gentle Laxative
Bisacodyl USP 5 mg
Stimulant Laxative

Gentle, predictable
overnight relief

25 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® Pink™.
50844      ORG101260756

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

Quality Plus 44-607

GENTLE LAXATIVE 
bisacodyl tablet, sugar coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50844-607
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 
D&C RED NO. 27 
FD&C YELLOW NO. 6 
FERROSOFERRIC OXIDE 
TRIETHYL CITRATE 
SHELLAC 
PROPYLPARABEN 
LACTOSE 
SUCRALOSE 
TALC 
FD&C BLUE NO. 2 
HYPROMELLOSES 
MAGNESIUM STEARATE 
METHYLPARABEN 
POLYDEXTROSE 
POVIDONE 
SODIUM ALGINATE 
SODIUM BENZOATE 
SODIUM BICARBONATE 
STEARIC ACID 
TITANIUM DIOXIDE 
TRIACETIN 
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize6mm
FlavorImprint Code5
Contains    
Packaging
#Item CodePackage Description
1NDC:50844-607-561 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 FINALpart33404/01/2013
Labeler - L.N.K. International, Inc. (038154464)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(50844-607)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(50844-607)

 
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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