OTC Medication Information: Bisacodyl

BISACODYL- 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.

Active ingredient (in each tablet)

Bisacodyl USP, 5 mg

Purpose

Stimulant laxative

Uses

  • for temporary 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 (1-800-222-1222) right away.

Directions

  • take with a glass of water
adults and children12 years and over take 1 to 3 tabletsin a single daily dose
children 6 to under12 years take 1 tablet in a singledaily dose
children under 6 years ask a doctor

Other information

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

  • avoid excessive humidity

  • see end flap for expiration date and lot number

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

Please reference the How Supplied section listed above for a description of individual tablets. 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:

Count5 mg
471610-219-04

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
20190801JH

PRINCIPAL DISPLAY PANEL — 5 mg

NDC 71610-219 — Bisacodyl EC, USP 5 mg

Bottle Label 5 mg
(click image for full-size original)

BISACODYL bisacodyl tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71610-219(NDC:0904-6748)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BISACODYL (DEACETYLBISACODYL) BISACODYL 5 mg
Inactive Ingredients
Ingredient Name Strength
ACACIA
CALCIUM CARBONATE
CARNAUBA WAX
SILICON DIOXIDE
STARCH, CORN
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
HYPROMELLOSE, UNSPECIFIED
FERROSOFERRIC OXIDE
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
METHYLPARABEN
POLYDEXTROSE
POLYETHYLENE GLYCOL, UNSPECIFIED
Polyvinyl Acetate Phthalate
POVIDONE
PROPYLENE GLYCOL
PROPYLPARABEN
SHELLAC
DIMETHICONE
WATER
SODIUM ALGINATE
SODIUM BENZOATE
SODIUM BICARBONATE
STEARIC ACID
SUCROSE
TALC
TITANIUM DIOXIDE
TRIACETIN
TRIETHYL CITRATE
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code 5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71610-219-02 2 TABLET, COATED in 1 BOTTLE, PLASTIC None
2 NDC:71610-219-03 3 TABLET, COATED in 1 BOTTLE, PLASTIC None
3 NDC:71610-219-04 4 TABLET, COATED in 1 BOTTLE, PLASTIC None
4 NDC:71610-219-08 8 TABLET, COATED in 1 BOTTLE, PLASTIC None
5 NDC:71610-219-20 20 TABLET, COATED in 1 BOTTLE, PLASTIC None
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 Operations
Aphena Pharma Solutions — Tennessee, LLC 128385585 REPACK (71610-219)

Revised: 08/2019 Aphena Pharma Solutions — Tennessee, LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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