BEVITROL- amylase, protease, lipase capsule 
Misemer Pharmaceutical

----------

Bevitrol

image description

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.

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.

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

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.

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

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

BEVITROL 
amylase, protease, lipase capsule
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:0276-0710
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PANCRELIPASE AMYLASE (UNII: YOJ58O116E) (PANCRELIPASE AMYLASE - UNII:YOJ58O116E) PANCRELIPASE AMYLASE112500 [USP'U]
PANCRELIPASE PROTEASE (UNII: 3560D81V50) (PANCRELIPASE PROTEASE - UNII:3560D81V50) PANCRELIPASE PROTEASE112500 [USP'U]
PANCRELIPASE LIPASE (UNII: 8MYC33932O) (PANCRELIPASE LIPASE - UNII:8MYC33932O) PANCRELIPASE LIPASE9000 [USP'U]
Inactive Ingredients
Ingredient NameStrength
GELATIN (UNII: 2G86QN327L)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:0276-0710-3030 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
dietary supplement12/01/2021
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
color
shape
size (solid drugs)20 mm
scoring1
color
Labeler - Misemer Pharmaceutical (784121365)
Registrant - Misemer Pharmaceutical (784121365)

Revised: 12/2021
Document Id: 8626b61a-2d58-4164-932f-142a69f05bbb
Set id: 3c304e4f-9f87-4a4a-82bb-927002f694d1
Version: 1
Effective Time: 20211215
 
Misemer Pharmaceutical