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NDC 71610-0054-65 SENNA 8.6 mg/1 Details
SENNA 8.6 mg/1
SENNA is a ORAL TABLET, COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, LLC. The primary component is SENNOSIDES A AND B.
MedlinePlus Drug Summary
Senna is used on a short-term basis to treat constipation. It also is used to empty the bowels before surgery and certain medical procedures. Senna is in a class of medications called stimulant laxatives. It works by increasing activity of the intestines to cause a bowel movement.
Related Packages: 71610-0054-65Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Senna
Product Information
| NDC | 71610-0054 |
|---|---|
| Product ID | 71610-054_de9c808c-32de-497e-95ce-3c93fa4f3cf1 |
| Associated GPIs | 46200060200303 |
| GCN Sequence Number | 019964 |
| GCN Sequence Number Description | sennosides TABLET 8.6 MG ORAL |
| HIC3 | D6S |
| HIC3 Description | LAXATIVES AND CATHARTICS |
| GCN | 00701 |
| HICL Sequence Number | 001289 |
| HICL Sequence Number Description | SENNOSIDES |
| Brand/Generic | Generic |
| Proprietary Name | SENNA |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | SENNA |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, COATED |
| Route | ORAL |
| Active Ingredient Strength | 8.6 |
| Active Ingredient Units | mg/1 |
| Substance Name | SENNOSIDES A AND B |
| Labeler Name | Aphena Pharma Solutions - Tennessee, LLC |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part334 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 71610-0054-65 (71610005465)
| NDC Package Code | 71610-054-65 |
|---|---|
| Billing NDC | 71610005465 |
| Package | 100 TABLET, COATED in 1 BOTTLE, PLASTIC (71610-054-65) |
| Marketing Start Date | 2018-04-26 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL fb426ee8-b582-405f-9ded-71aea6bf2640 Details
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 | 8.6 mg |
| 100 | 71610-054-65 |
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
20180427JH
INGREDIENTS AND APPEARANCE
| SENNA
senna tablet, coated |
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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(71610-054) | |