BISACODYL- bisacodyl tablet, coated
REMEDYREPACK INC.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Major 44-327

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
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.

Directions

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, 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 or comments?

(800)-616-2471

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

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

Remedy_Label

MM2

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	Marketing End Date
Packaging
1	NDC:70518-1864-0	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	02/13/2019	10/13/2023
2	NDC:70518-1864-1	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	05/28/2020	01/12/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		02/13/2019	10/13/2023

Labeler - REMEDYREPACK INC. (829572556)

Revised: 10/2023

Document Id: 079a8e12-0aed-096d-e063-6294a90afc0b

Set id: f8e9ff6d-9627-41ca-b8ee-c3f3705e6bb9

Version: 7

Effective Time: 20231013

REMEDYREPACK INC.