BEVITROL- amylase, protease, lipase capsule

Bevitrol by

Drug Labeling and Warnings

Bevitrol by is a Other medication manufactured, distributed, or labeled by Misemer Pharmaceutical. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

STATEMENT OF IDENTITY

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

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

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

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

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

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

INGREDIENTS AND APPEARANCE

BEVITROL 
amylase, protease, lipase capsule

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:0276-0710
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PANCRELIPASE AMYLASE (UNII: YOJ58O116E) (PANCRELIPASE AMYLASE - UNII:YOJ58O116E)	PANCRELIPASE AMYLASE	112500 [USP'U]
PANCRELIPASE PROTEASE (UNII: 3560D81V50) (PANCRELIPASE PROTEASE - UNII:3560D81V50)	PANCRELIPASE PROTEASE	112500 [USP'U]
PANCRELIPASE LIPASE (UNII: 8MYC33932O) (PANCRELIPASE LIPASE - UNII:8MYC33932O)	PANCRELIPASE LIPASE	9000 [USP'U]

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:0276-0710-30	30 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
dietary supplement		12/01/2021

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
shape
size (solid drugs)	20 mm
scoring	1
color

Labeler - Misemer Pharmaceutical (784121365)

Registrant - Misemer Pharmaceutical (784121365)