GENTLE LAXATIVE- bisacodyl tablet, sugar coated

Gentle Laxative by

Drug Labeling and Warnings

Gentle Laxative by is a Otc medication manufactured, distributed, or labeled by Wal-Mart Stores Inc, 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

Stimulant laxative

Warnings

• for relief of occasional constipation and irregularity
  
• this product generally produces bowel movement in 6 to 12 hours
  

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 need to use a laxative for more than 1 week
  
• you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
  

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 children12 years and over: take 1 to 3 tablets; in a single daily; dose
• children 6 to under12 years: take 1 tablet in a; single daily dose
• children under6 years: ask a doctor

Other information

• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  
• avoid excessive humidity
  
• use by expiration date on package
  

Inactive ingredients

acacia, ammonium hydroxide, calcium carbonate, carnauba wax, colloidal anhydrous silica, 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 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?

1-888-287-1915

Principal display panel

Equate™

NDC: 49035-706-12

Compare to Dulcolax Pink® active ingredient*

Gentle
Laxative
Bisacodyl USP, 5 mg
Stimulant Laxative

Gentle, dependable constipation relief

Actual Size

5
mg
EACH

100
TABLETS

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716
PRODUCT OF INDIA

*This product is not manufactured or distributed by Sanofi-Aventis Deutschland GMBH, owner of the registered trademark Dulcolax Pink®.

50844   ORG011960712

Equate 44-607

INGREDIENTS AND APPEARANCE

GENTLE LAXATIVE 
bisacodyl tablet, sugar coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-706
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
ACACIA (UNII: 5C5403N26O)
AMMONIA (UNII: 5138Q19F1X)
CALCIUM CARBONATE (UNII: H0G9379FGK)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
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)
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-706-12	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/17/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	12/17/2019

Labeler - Wal-Mart Stores Inc (051957769)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(49035-706)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(49035-706)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(49035-706)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(49035-706)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(49035-706)