441

441
SPL v4
SPL
SPL Set ID 0331c762-d318-48d6-97ed-86499c6c8b30
Route
ORAL
Published
Effective Date 2020-07-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Deacetylbisacodyl (5 mg)
Inactive Ingredients
Acacia Ammonia Calcium Carbonate Carnauba Wax Starch, Corn D&c Yellow No. 10 Fd&c Yellow No. 6 Hypromelloses Ferrosoferric Oxide Lactose Monohydrate Magnesium Stearate Methylparaben Polydextrose Polyethylene Glycol, Unspecified Polyvinyl Acetate Phthalate Propylparaben Propylene Glycol Povidone Shellac Dimethicone Silicon Dioxide Sodium Alginate Sodium Benzoate Sodium Bicarbonate Stearic Acid Sucrose Talc Titanium Dioxide Triacetin Triethyl Citrate

Identifiers & Packaging

Pill Appearance
Imprint: 5 Shape: round Color: orange Size: 6 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2000-01-01

Description

Bisacodyl 5 mg

Purpose

Stimulant Laxative


Medication Information

Purpose

Stimulant Laxative

Description

Bisacodyl 5 mg

Uses
  • relieves occasional constipation and irregularity
  • generally produces a bowel movement in 6 to 12 hours
Section 50565-1

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Warnings

Do not use



• for more than one week unless directed by a doctor



• if you cannot swallow without chewing



• within 1 hour after taking an antacid or milk

Ask a doctor before use if you have



• abdominal pain



• nausea



• vomiting



• a sudden change in bowel habits that lasts longer than 2 weeks

When using this product• abdominal discomfort, faintness, or cramps may occur

Stop use and ask a doctor



• if you have no bowel movement within 12 hours



• if you have rectal bleeding



• these could be signs of a serious condition

If pregnant or breast-feeding,ask a health professional before use.

Directions

• do not take more than directed

• swallow whole, do not chew or crush

• take recommended dose in a single daily dose

• take with water

• adults and children 12 years and older: take 1-3 (usually 2) tablets daily

• children 12 and under: ask a doctor

Other Information

• store at room temperature

• avoid excessive humidity

• Tamper Evident: Do not use if imprinted seal under cap is missing or broken

• package not child resistant

• for institutional use only

Inactive Ingredients

Acacia, Ammonium Hydroxide, Calcium Carbonate, Corn Starch, D and C Yellow NO. 10 Lake, FD and C Yellow NO. 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. May also contain: Calcium Sulfate, Gelatin, Sodium Starch Glycolate.

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:

Count 5 mg
2 71610-453-02
4 71610-453-04
20 71610-453-20

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



20200805JH

Principal Display Panel 5 Mg

NDC 71610-453 - Bisacodyl 5 mg Tablets

Active Ingredient (in Each Tablet)

Bisacodyl 5 mg


Structured Label Content

Uses
  • relieves occasional constipation and irregularity
  • generally produces a bowel movement in 6 to 12 hours
Section 50565-1 (50565-1)

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Purpose

Stimulant Laxative

Warnings

Do not use



• for more than one week unless directed by a doctor



• if you cannot swallow without chewing



• within 1 hour after taking an antacid or milk

Ask a doctor before use if you have



• abdominal pain



• nausea



• vomiting



• a sudden change in bowel habits that lasts longer than 2 weeks

When using this product• abdominal discomfort, faintness, or cramps may occur

Stop use and ask a doctor



• if you have no bowel movement within 12 hours



• if you have rectal bleeding



• these could be signs of a serious condition

If pregnant or breast-feeding,ask a health professional before use.

Directions

• do not take more than directed

• swallow whole, do not chew or crush

• take recommended dose in a single daily dose

• take with water

• adults and children 12 years and older: take 1-3 (usually 2) tablets daily

• children 12 and under: ask a doctor

Other Information (Other information)

• store at room temperature

• avoid excessive humidity

• Tamper Evident: Do not use if imprinted seal under cap is missing or broken

• package not child resistant

• for institutional use only

Inactive Ingredients (Inactive ingredients)

Acacia, Ammonium Hydroxide, Calcium Carbonate, Corn Starch, D and C Yellow NO. 10 Lake, FD and C Yellow NO. 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. May also contain: Calcium Sulfate, Gelatin, Sodium Starch Glycolate.

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:

Count 5 mg
2 71610-453-02
4 71610-453-04
20 71610-453-20

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



20200805JH

Principal Display Panel 5 Mg (PRINCIPAL DISPLAY PANEL - 5 mg)

NDC 71610-453 - Bisacodyl 5 mg Tablets

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Bisacodyl 5 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)