Active ingredient (in each tablet)

Bisacodyl USP, 5 mg

Purpose

Stimulant laxative

Uses

for 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
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

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, calcium carbonate, carnauba wax, colloidal anhydrous silica, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, iron oxide black, lactose anhydrous, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, methylparaben, polydextrose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, propylparaben, shellac glaze, simethicone, sodium benzoate, sodium bicarbonate, sodium lauryl sulfate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate

Questions or comments?

1-800-426-9391

Principal display panel

NDC 0904-6748-80

Compare to the active ingredient
in Dulcolax® Laxative Tablets*

Major®

bisacodyl USP

bisacodyl USP
5 mg

Stimulant Laxative

Gentle, Dependable
Constipation Relief

Actual Size

1000 TABLETS
Comfort Coated Tablets

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

*This product is not manufactured or distributed by A. Nattermann & Cie. GmbH,
owner of the registered trademark Dulcolax® Laxative Tablets.
50844 ORG042532716

Distributed by:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
(800) 616-2471
www.major-rugby.com

Rev. 10/25 M-17 Re-order No. 700927

Major 44-327A

BISACODYL
bisacodyl tablet, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0904-6748
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)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)
FD&C YELLOW NO. 6 ALUMINUM LAKE (UNII: GYP6Z2JR6Q)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SHELLAC (UNII: 46N107B71O)
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0904-6748-17	1 in 1 CARTON	12/01/2018
1		25 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:0904-6748-60	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/01/2018
3	NDC:0904-6748-80	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	505G(a)(3)	12/01/2018

Labeler - Major Pharmaceuticals (191427277)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	manufacture(0904-6748) , pack(0904-6748)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	manufacture(0904-6748) , pack(0904-6748)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	manufacture(0904-6748)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(0904-6748)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		117025878	manufacture(0904-6748)