GENTLE LAXATIVE- bisacodyl tablet, coated
L.N.K. International, Inc.

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.

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Quality Plus 44-327-delisted

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50844-327
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y)	BISACODYL	5 mg

Ingredient Name	Strength
Inactive Ingredients
ACACIA (UNII: 5C5403N26O)
CALCIUM CARBONATE (UNII: H0G9379FGK)
CARNAUBA WAX (UNII: R12CBM0EIZ)
STARCH, CORN (UNII: O8232NY3SJ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SHELLAC (UNII: 46N107B71O)
SODIUM ALGINATE (UNII: C269C4G2ZQ)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
AMMONIA (UNII: 5138Q19F1X)
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	ORANGE	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	5
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50844-327-15	2 in 1 CARTON	03/25/2002	10/29/2020
1		25 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part334	03/25/2002	10/29/2020

Labeler - L.N.K. International, Inc. (038154464)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	PACK(50844-327)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	MANUFACTURE(50844-327)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	PACK(50844-327)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	PACK(50844-327)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	PACK(50844-327)

Revised: 10/2020

Document Id: 433c6d6e-da45-420a-9c6a-49d5415116d0

Set id: c4ff36f2-6cdc-4d8a-a268-2919745047db

Version: 6

Effective Time: 20201029

L.N.K. International, Inc.