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NDC 71610-0058-65 SENEXON 8.6 mg/1 Details
SENEXON 8.6 mg/1
SENEXON 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.
Product Information
| NDC | 71610-0058 |
|---|---|
| Product ID | 71610-058_81c8d20a-3679-423a-8916-a1e5dcde0fbf |
| 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 | SENEXON |
| 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 71610-0058-65 (71610005865)
| NDC Package Code | 71610-058-65 |
|---|---|
| Billing NDC | 71610005865 |
| Package | 100 TABLET, COATED in 1 BOTTLE, PLASTIC (71610-058-65) |
| Marketing Start Date | 2018-05-04 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 18c77552-9e65-4e73-9e41-59f91075ce94 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Dosage and Administration
Adults and children 12 years and over - 2 tablets once a day - maximum dosage - 4 tablets twice a day
Children 6 to under 12 years - 1 tablet once a day maximum dosage - 2 tablets twice a day
children 2 to under 6 years - 1/2 tablet once a day - maximum dosage - 1 tablet twice a day
SPL UNCLASSIFIED SECTION
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 | 71610-058-65 |
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
20180514JH
INGREDIENTS AND APPEARANCE
| SENEXON
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(71610-058) | |