DailyMed - BISACODYL tablet, coated

Contains inactivated NDC Code(s)
NDC Code(s): 70518-1864-0, 70518-1864-1
Packager: REMEDYREPACK INC.
This is a repackaged label.
Source NDC Code(s): 0904-6748

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated March 15, 2022

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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 ...
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
- 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
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

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 single daily dose - children ...

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
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- avoid excessive humidity
- use by expiration date on package
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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?
(800)-616-2471

(800)-616-2471
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PRINCIPAL DISPLAY PANEL
DRUG: Bisacodyl - GENERIC: Bisacodyl - DOSAGE: TABLET, COATED - ADMINSTRATION: ORAL - NDC: 70518-1864-0 - NDC: 70518-1864-1 - COLOR: orange - SHAPE: ROUND - SCORE: No score - SIZE: 6 mm - IMPRINT: 5 - PACKAGING: 30 in 1 ...
DRUG: Bisacodyl

GENERIC: Bisacodyl

DOSAGE: TABLET, COATED

ADMINSTRATION: ORAL

NDC: 70518-1864-0

NDC: 70518-1864-1

COLOR: orange

SHAPE: ROUND

SCORE: No score

SIZE: 6 mm

IMPRINT: 5

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):
- BISACODYL 5mg in 1
INACTIVE INGREDIENT(S):
- POVIDONE, UNSPECIFIED
- TRIACETIN
- TITANIUM DIOXIDE
- TALC
- SUCROSE
- STEARIC ACID
- SODIUM BICARBONATE
- SODIUM BENZOATE
- SODIUM ALGINATE
- WATER
- DIMETHICONE
- SHELLAC
- PROPYLPARABEN
- PROPYLENE GLYCOL
- TRIETHYL CITRATE
- AMMONIA
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POLYDEXTROSE
- METHYLPARABEN
- MAGNESIUM STEARATE
- ANHYDROUS LACTOSE
- FERROSOFERRIC OXIDE
- HYPROMELLOSE, UNSPECIFIED
- FD&C YELLOW NO. 6
- D&C YELLOW NO. 10 ALUMINUM LAKE
- STARCH, CORN
- SILICON DIOXIDE
- CARNAUBA WAX
- CALCIUM CARBONATE
- Polyvinyl Acetate Phthalate
- ACACIA
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INGREDIENTS AND APPEARANCE

Product Information

BISACODYL bisacodyl tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70518-1864(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)
STARCH, CORN (UNII: O8232NY3SJ)
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)
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, 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)
AMMONIA (UNII: 5138Q19F1X)

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:70518-1864-0	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	02/13/2019
2	NDC:70518-1864-1	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	05/28/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	02/13/2019

Labeler - REMEDYREPACK INC. (829572556)

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Published Date (What is this?)	Version	Files
Mar 16, 2022	6 (current)	download
Jun 17, 2021	5	download
Jan 20, 2021	4	download
Nov 5, 2019	3	download
Feb 15, 2019	1	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, coated

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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	70518-1864-0 (inactivated)
2	70518-1864-1 (inactivated)

Label: BISACODYL tablet, coated

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, coated

Number of versions: 5

BISACODYL tablet, coated

BISACODYL tablet, coated

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BISACODYL tablet, coated

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