441
0331c762-d318-48d6-97ed-86499c6c8b30
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
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)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:05:17.220897 · Updated: 2026-03-14T23:06:51.816479