Label: BEVITROL- amylase, protease, lipase capsule
- NHRIC Code(s): 0276-0710-30
- Packager: Misemer Pharmaceutical
- Category: DIETARY SUPPLEMENT
Drug Label Information
Updated December 15, 2021
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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.
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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
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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
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INGREDIENTS AND APPEARANCE
BEVITROL
amylase, protease, lipase capsuleProduct 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)