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NDC 71610-0453-02 stimulant laxative enteric coated 5 mg/1 Details
stimulant laxative enteric coated 5 mg/1
stimulant laxative enteric coated is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, LLC. The primary component is BISACODYL.
MedlinePlus Drug Summary
Bisacodyl is used on a short-term basis to treat constipation. It also is used to empty the bowels before surgery and certain medical procedures. Bisacodyl is in a class of medications called stimulant laxatives. It works by increasing activity of the intestines to cause a bowel movement.
Related Packages: 71610-0453-02Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Bisacodyl
Product Information
| NDC | 71610-0453 |
|---|---|
| Product ID | 71610-453_5fb2da10-483f-4431-a408-ffb37dcc06a0 |
| Associated GPIs | 46200010000610 |
| GCN Sequence Number | 002947 |
| GCN Sequence Number Description | bisacodyl TABLET DR 5 MG ORAL |
| HIC3 | D6S |
| HIC3 Description | LAXATIVES AND CATHARTICS |
| GCN | 08762 |
| HICL Sequence Number | 001301 |
| HICL Sequence Number Description | BISACODYL |
| Brand/Generic | Generic |
| Proprietary Name | stimulant laxative enteric coated |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Bisacodyl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/1 |
| Substance Name | BISACODYL |
| Labeler Name | Aphena Pharma Solutions - Tennessee, LLC |
| Pharmaceutical Class | Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part334 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 71610-0453-02 (71610045302)
| NDC Package Code | 71610-453-02 |
|---|---|
| Billing NDC | 71610045302 |
| Package | 2 TABLET in 1 BOTTLE (71610-453-02) |
| Marketing Start Date | 2020-08-28 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 0331c762-d318-48d6-97ed-86499c6c8b30 Details
Uses
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
Other information
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
INGREDIENTS AND APPEARANCE
| STIMULANT LAXATIVE ENTERIC COATED
bisacodyl tablet |
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| Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Aphena Pharma Solutions - Tennessee, LLC | 128385585 | REPACK(71610-453) | |