GENTLE LAXATIVE- bisacodyl tablet, delayed release

Gentle Laxative by

Drug Labeling and Warnings

Gentle Laxative by is a Otc medication manufactured, distributed, or labeled by H E B, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Bisacodyl USP, 5 mg

Purpose

Stimulant laxative 

Uses

• for relief of occasional constipation (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
• it may cause 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 right away. 

Directions

• do not take more than directed
• 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: take 1 tablet in a single daily ; dose
• children under 6 years: ask a doctor

Other information

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

Inactive ingredients

carmine, colloidal silicon dioxide, corn starch, FD&C red #40 aluminum lake, hypromellose, lactose anhydrous, magnesium stearate, methacrylic acid, microcrystalline cellulose, polydextrose, polyethylene glycol, shellac wax, simethicone, sodium bicarbonate, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate

Questions or comments?

1-800-426-9391 

Principal Display Panel

H-E-B®

NDC: 37808-680-11

Gentle
Laxative
Bisacodyl USP, 5 mg

Stimulant Laxative

Gentle
Overnight Relief

60 ENTERIC
COATED TABLETS

actual
size

TAMPER EVIDENT: DO NOT
USE IF PACKAGE IS OPENED
OR IF BLISTER UNIT IS
TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERING

MADE WITH PRIDE AND CARE FOR
H-E-B®, SAN ANTONIO, TX 78204

50844    REV0923C67611

100%
GUARANTEE
promise

HEB 44-676A

INGREDIENTS AND APPEARANCE

GENTLE LAXATIVE 
bisacodyl tablet, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37808-680
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
FD&C RED NO. 40 ALUMINUM LAKE (UNII: 6T47AS764T)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHACRYLIC ACID (UNII: 1CS02G8656)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SHELLAC (UNII: 46N107B71O)
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

Product Characteristics
Color	pink	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	B
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37808-680-11	4 in 1 CARTON	09/10/2024
1		15 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	09/10/2024

Labeler - H E B (007924756)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	pack(37808-680)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	manufacture(37808-680) , pack(37808-680)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	manufacture(37808-680)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	pack(37808-680)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		117025878	manufacture(37808-680)