Bisacodyl by RELIABLE 1 LABORATORIES LLC rel 441

Drug Details [pdf]

BISACODYL- bisacodyl tablet, coated
RELIABLE 1 LABORATORIES LLC

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rel 441

Active ingredient (in each tablet)

Bisacodyl 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, vomiting
noticed 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

you have rectal bleeding or no bowel movement after using this product.

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 older: take 1 to 3 tablets in a single daily dose
children 12 and under: ask a doctor

Other information

Tamper Evident: Do not use if imprinted seal under cap is missing or broken
store at room temperature15°-30°C (59°-86°F)
avoid excessive humidity
package not child resistant

Inactive ingredients

Acacia, Ammonium Hydroxide,
Calcium Carbonate, Corn Starch, D&C Yellow #10 Lake,
FD&C Yellow #6 Lake, Hypromellose, Iron Oxide Black,
Lactose, Magnesium Stearate, Methylparaben, PEG,
Polydextrose, Polyvinyl Acetate Phthalate, Propylparaben,
Propylene Glycol, Povidone, Shellac, Simethicone, Silica,
Sodium Alginate, Sodium Benzoate, Sodium Bicarbonate,
Stearic Acid, Sucrose, Talc, Titanium Dioxide, Triacetin,
Triethyl Citrate, Wax.

Questions or comments?

call 516-341-0666,
8:30 am - 4:30 pm ET, Monday - Friday

Package Label

BISACODYL
bisacodyl tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69618-058
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
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)
ACACIA (UNII: 5C5403N26O)
AMMONIA (UNII: 5138Q19F1X)
CALCIUM CARBONATE (UNII: H0G9379FGK)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
STARCH, CORN (UNII: O8232NY3SJ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
HYPROMELLOSES (UNII: 3NXW29V3WO)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POVIDONE (UNII: FZ989GH94E)
SHELLAC (UNII: 46N107B71O)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

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: 69618-058-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M007	01/01/2020	01/31/2024

Labeler - RELIABLE 1 LABORATORIES LLC (079718111)

Registrant - Geri-Care Pharmaceutical Corp (611196254)

Revised: 10/2023

Document Id: 0864ecf0-4b0f-715e-e063-6294a90a1778

Set id: b60c85d7-5eb1-aab9-e053-2a95a90a4361

Version: 4

Effective Time: 20231023