BISACODYL tablet, delayed release

Bisacodyl by

Drug Labeling and Warnings

Bisacodyl by is a Otc medication manufactured, distributed, or labeled by Aphena Pharma Solutions - Tennessee, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Repackaging Information

This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

• Count: 5 mg
• 2: 71610-700-02
• 3: 71610-700-03
• 4: 71610-700-04
• 6: 71610-700-06
• 8: 71610-700-08
• 20: 71610-700-20

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:

Cookeville, TN 38506

20230406JK

PRINCIPAL DISPLAY PANEL - 5 mg

NDC: 71610-700 - Bisacodyl EC, USP 5 mg Tablets - Rx Only

INGREDIENTS AND APPEARANCE

BISACODYL 
bisacodyl tablet, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71610-700(NDC:0904-6748)
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)
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 (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)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71610-700-02	2 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/03/2023
2	NDC: 71610-700-03	3 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/03/2023
3	NDC: 71610-700-04	4 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/03/2023
4	NDC: 71610-700-06	6 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/03/2023
5	NDC: 71610-700-08	8 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/03/2023
6	NDC: 71610-700-20	20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/03/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	12/01/2018

Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)

Establishment
Name	Address	ID/FEI	Business Operations
Aphena Pharma Solutions - Tennessee, LLC		128385585	REPACK(71610-700)