BISACODYL ENTERIC COATED- bisacodyl tablet, coated 
Aphena Pharma Solutions - Tennessee, LLC

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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Bisacodyl Enteric Coated Tablet

Active ingredient(s)

 Bisacodyl 5mg

Purpose

 Stimulant laxative

Use(s)

 -relieves occasional constipation and irregularity

 -this product generally produces bowel movement in 6 to 12 hours

Warnings

Do not use

 Do not use if you cannot swallow without chewing

Ask a doctor before use if

 -you have a sudden change in bowel habits that lasts more than 2 weeks

-stomach pain, nausea or vomiting

When using this product

 -do not use within 1 hour after taking an antacid or milk

-do not chew or crush tablet(s)

-you may have stomach discomfort, faintness or 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 professions before use.

Keep out of reach of children

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 of age - take 1 tablet in a single daily dose

children under 6 years of age - ask a doctor

Other information

Repackaged by Aphena Pharma Solutions - TN.
See Repackaging Information for available configurations.
Aphena Pharma Solutions - TN

Storage

 -store at 25 degrees C (77 degrees F) excursions permitted between 15 degrees-30 degrees C (59 degrees-86 degrees F)

-use by expiration date on package

-protect from excessive humidity

Inactive ingredients

acacia, bees wax, calcium sulfate, carnauba wax, cellulose, corn starch, D&C Yellow No. 10 lake, FD&C Yellow No. 6 lake, gelatin, lactose, magnesium stearate, pharmaceutical glaze, polyvinyl acetate phthalate, silica gel, sodium starch glycolate, stearinc acid, sugar, talc, titanium dioxide.

Questions

 To Report Adverse Drug Event call: (800) 616-2471

Repackaging Information

Please reference the Product Characteristics section listed below for a description of individual tablets or capsules. 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:

Count4mg
0467544-655-04
0667544-655-06

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:
Aphena Pharma Solutions - TN
Cookeville, TN 38506

20130612AW

PRINCIPAL DISPLAY PANEL - 5mg

NDC 67544-655 - Bisacodyl 5mg
Bottle Label 5mg

BISACODYL  ENTERIC COATED
bisacodyl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67544-655(NDC:0904-7927)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL5 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA (UNII: 5C5403N26O)  
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
AMMONIUM NONOXYNOL-4 SULFATE (UNII: 9HIA70O4J0)  
SHELLAC (UNII: 46N107B71O)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3)  
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize6mm
FlavorImprint Code 5
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67544-655-0404 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2010
2NDC:67544-655-0606 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/29/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33410/24/2008
Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)
Establishment
NameAddressID/FEIBusiness Operations
Aphena Pharma Solutions - Tennessee, LLC128385585Repack(67544-655)

Revised: 12/2019
Document Id: df0a770a-eddd-4adc-96db-02da3cf01657
Set id: 458f701f-6f74-46c7-a801-6669cbf1b5b5
Version: 2
Effective Time: 20191223
 
Aphena Pharma Solutions - Tennessee, LLC