Bevitrol
- Manufacturer
- Misemer Pharmaceutical
- Effective date
- 2021-12-15
- Label type
- Dietary Supplement
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 02:50:16
Label at a glance#
ProductBevitrol
Active ingredientPANCRELIPASE AMYLASE, PANCRELIPASE PROTEASE, PANCRELIPASE LIPASE
Label structure7 sections
Contacts and useful links#
Label contents#
Full prescribing information#
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Statement of Identity section
Bevitrol is an orally administered prescription digestive enzyme dietary supplement formulation for the clinical dietary
management of suboptimal nutritional status in patients where advanced supplementation is required and nutritional
supplementation in physiologically stressful conditions for maintenance of good health is needed.
Bevitrol should be administered under the supervision of a licensed medical practitioner.
DOSAGE & ADMINISTRATION SECTION
Bevitrol is an orally administered prescription digestive enzyme supplement formulation for the clinical dietary
management of suboptimal nutritional status in patients where advanced supplementation is required and nutritional
supplementation in physiologically stressful conditions for maintenance of good health is needed.
Usual adult dose is 1 capsule daily with or without food. Do not exceed 3 capsules per day.
HEALTH CLAIM SECTION
Bevitrol is intended for the dietary management of a patient who, because of therapeutic or chronic medical needs, has
limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has
other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the
modification of a normal diet alone.
All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.
This product may be administered only under a physician’s supervision. There are no implied or explicit claims on
therapeutic equivalence.
Manufactured for:
Misemer Pharmaceutical, Inc.
Ripley, MS 38663
Item 0710
Rev. 0921
PRECAUTIONS SECTION
Bevitrol should only be used under the direction and supervision of a licensed medical practitioner. Use with caution
in patients that may have a medical condition, are pregnant, lactating, trying to conceive, under the age of 18, or taking
medications.
SAFE HANDLING WARNING SECTION
Bevitrol is supplied as red and white capsules dispensed in white HDPE plastic bottles of 30ct.
Item 0276-0710-30
Store at controlled room temperature 15°-30°C (59°F-86°F). Keep in cool dry place. Call your doctor about side effects.
You may report side effects to FDA at 1-800-FDA-1088. KEEP THIS OUT OF THE REACH OF CHILDREN.
Dispense by Prescription
WARNINGS SECTION
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 2173926 | lipase 9000 UNT / amylase 112,500 UNT / protease 112,500 UNT Oral Capsule | PSN | 1 |
| 2173926 | amylase 112500 UNT / lipase 9000 UNT / protease 112500 UNT Oral Capsule | SCD | 1 |
| 2173926 | amylase 112,500 UNT / protease 112,500 UNT / lipase 9000 UNT Oral Capsule | SY | 1 |
| 2173926 | amylases 112,500 UNT / endopeptidases 112,500 UNT / lipase 9000 UNT Oral Capsule | SY | 1 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0b1603b8-969e-b082-f6f5-ad66d8a6ea8a | Product name | 2 | 20200325 |
| 19041f15-771b-3d3a-88fc-f5e2d079cd6d | Product name | 2 | 20200325 |
| 1987d950-08e4-4b70-adeb-fb67a71142ab | Product name | 2 | 20200325 |
| 8825ddf7-1520-4680-b0ee-684e2fa73672 | Product name | 2 | 20200325 |
| 267a6f34-90b4-2f48-3063-4f505d06a7be | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0276-0710-30 | Bevitrol | 30 in 1 BOTTLE | CAPSULE | 30 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0276-0710-30 | EA - Each | 0276-0710 | 70f1a805-c66b-4c18-9e22-e89146b690f6 | 1 | 2022-01-06 |
Products#
Every source-derived product name is available through these pages.
- Bevitrol
- Amylase, Protease, Lipase
- PANCRELIPASE AMYLASE
- PANCRELIPASE PROTEASE
- PANCRELIPASE LIPASE
- GELATIN
- MICROCRYSTALLINE CELLULOSE
- MAGNESIUM STEARATE
- FD&C RED NO. 40
- FD&C BLUE NO. 1
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0276-0710 | 0276-0710-30 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PANCRELIPASE AMYLASE | YOJ58O116E | ACTIB |
| PANCRELIPASE PROTEASE | 3560D81V50 | ACTIB |
| PANCRELIPASE LIPASE | 8MYC33932O | ACTIB |
| GELATIN | 2G86QN327L | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
Source Document#
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.