DailyMed - BISACODYL tablet, delayed release

NDC Code(s): 0904-6748-17, 0904-6748-60, 0904-6748-80
Packager: Major Pharmaceuticals

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None

Drug Label Information

Updated January 28, 2025

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Active ingredient (in each tablet)
Bisacodyl USP, 5 mg

Bisacodyl USP, 5 mg
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Purpose
Stimulant laxative

Stimulant laxative
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Uses
for relief of occasional constipation and irregularity - this product generally produces bowel movement in 6 to 12 hours
- for relief of occasional constipation and irregularity
- this product generally produces bowel movement in 6 to 12 hours
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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 ...
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.

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Directions
do not take more than directed - take with a glass of water - adults and children 12 years and overtake 1 to 3 tablets in a single daily dose - children 6 to under 12 yearstake 1 tablet in a ...
- 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

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Other information
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN - store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) avoid excessive humidity - see end flap ...
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- avoid excessive humidity
- see end flap for expiration date and lot number
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Inactive ingredients
acacia, ammonium hydroxide, calcium carbonate, carnauba wax, colloidal anhydrous silica, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, iron oxide black ...

acacia, ammonium hydroxide, calcium carbonate, carnauba wax, colloidal anhydrous silica, corn starch, D&C yellow #10 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

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Questions or comments?
1-800-426-9391

1-800-426-9391
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Principal display panel
NDC 0904-6748-17 - Compare to the active ingredient - in Dulcolax® Laxative Tablets* Major® Bisacodyl USP - 5 mg - Stimulant Laxative - Gentle, Dependable - Constipation Relief - Actual Size - 25 ...

NDC 0904-6748-17

Compare to the active ingredient
in Dulcolax® Laxative Tablets*

Major®

Bisacodyl USP
5 mg

Stimulant Laxative

Gentle, Dependable
Constipation Relief

Actual Size

25 TABLETS
Comfort Coated Tablets

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

*This product is not manufactured or distributed by A. Nattermann & Cie. GmbH,
owner of the registered trademark Dulcolax® Laxative Tablets.
50844 REV0923C32756

Distributed by:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
Questions or comments?
Call (800) 616-2471
www.majorpharmaceuticals.com

Rev. 12/23 M-17 Re-order No. 700929

Major 44-327

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INGREDIENTS AND APPEARANCE

Product Information

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)
AMMONIA (UNII: 5138Q19F1X)
CALCIUM CARBONATE (UNII: H0G9379FGK)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
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)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SHELLAC (UNII: 46N107B71O)
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
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)

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)

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Published Date (What is this?)	Version	Files
Jan 30, 2025	12 (current)	download
Jan 16, 2024	11	download
Oct 9, 2023	10	download
Aug 2, 2023	9	download
Aug 18, 2022	8	download
Aug 4, 2021	7	download
Mar 10, 2021	6	download
Mar 6, 2020	5	download
Mar 28, 2019	4	download
Dec 3, 2018	3	download

	RxCUI	RxNorm NAME	RxTTY
1	308753	bisacodyl 5 MG Delayed Release Oral Tablet	PSN
2	308753	bisacodyl 5 MG Delayed Release Oral Tablet	SCD
3	308753	bisacodyl 5 MG Enteric Coated Oral Tablet	SY

Label: BISACODYL tablet, delayed release

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Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if you have

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

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

	NDC
1	0904-6748-17
2	0904-6748-60
3	0904-6748-80

Label: BISACODYL tablet, delayed release

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if you have

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

BISACODYL tablet, delayed release

Number of versions: 10

BISACODYL tablet, delayed release

BISACODYL tablet, delayed release

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BISACODYL tablet, delayed release

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.