404 - Laxative Bisacodyl 5mg

Bisacodyl Laxative by

Drug Labeling and Warnings

Bisacodyl Laxative by is a Otc medication manufactured, distributed, or labeled by Good Sense. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BISACODYL LAXATIVE- bisacodyl tablet, coated 
Good Sense

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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404 - Laxative Bisacodyl 5mg

Active ingredient(s)

Bisacodyl USP 5mg

Purpose

Stimulant Laxative

Use(s)

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

Warnings

Do not use

you cannot swallow without chewing

Ask a doctor before use if

• 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
• you may have 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

Pregnancy/Breastfeeding

ask a health professional before use.

Keep out of reach of children

In case of accidental overdose, get medical help or contact a doctor or Poison Control Center (1-800-222-1222) right away.

Directions

• take with a glass of water

adults and children 12 years of age 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 of age: ask a doctor

Other information

do not use if blister unit is broken or torn

Storage

store between 68º to 77ºF (20º to 25ºC)

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, 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

Call 1-800-719-9260 Monday through Friday 9AM – 5PM

Principal Display Panel

Bisacodyl Laxative

BISACODYL LAXATIVE 
bisacodyl tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50804-404
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)	Â
AMMONIA (UNII: 5138Q19F1X)	Â
CALCIUM CARBONATE (UNII: H0G9379FGK)	Â
CARNAUBA WAX (UNII: R12CBM0EIZ)	Â
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)	Â
STARCH, CORN (UNII: O8232NY3SJ)	Â
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)	Â
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)	Â
HYPROMELLOSES (UNII: 3NXW29V3WO)	Â
FERROUS OXIDE (UNII: G7036X8B5H)	Â
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)	Â
MAGNESIUM STEARATE (UNII: 70097M6I30)	Â
METHYLPARABEN (UNII: A2I8C7HI9T)	Â
POLYDEXTROSE (UNII: VH2XOU12IE)	Â
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)	Â
Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3)	Â
POVIDONE (UNII: FZ989GH94E)	Â
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	Â
PROPYLPARABEN (UNII: Z8IX2SC1OH)	Â
SHELLAC (UNII: 46N107B71O)	Â
TRIMETHYLSILANE (UNII: 9L70DJH2K0)	Â
SODIUM ALGINATE (UNII: C269C4G2ZQ)	Â
SODIUM BENZOATE (UNII: OJ245FE5EU)	Â
SODIUM BICARBONATE (UNII: 8MDF5V39QO)	Â
STEARIC ACID (UNII: 4ELV7Z65AP)	Â
SUCROSE (UNII: C151H8M554)	Â
TALC (UNII: 7SEV7J4R1U)	Â
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)	Â
TRIACETIN (UNII: XHX3C3X673)	Â
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)	Â

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50804-404-92	1 in 1 CARTON	06/18/2021	12/15/2021
1		25 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 not final	part334	03/25/2002	12/15/2021

Labeler - Good Sense (076059836)

Revised: 6/2021

Document Id: 280c9fbe-dbd6-4c51-98d1-5164a6b5ae1a

34390-5

Set id: d05ba873-2603-47a2-9ae6-e5773f4a64ef

Version: 2

Effective Time: 20210618

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