Label: ENZADYNE- proamylipase capsule
- NHRIC Code(s): 69336-403-30
- Packager: Sterling Knight Pharmaceuticals LLC
- Category: DIETARY SUPPLEMENT
Drug Label Information
Updated June 18, 2019
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- HEALTH CLAIM:
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DESCRIPTION:
Enzadyne is an orally administered prescription digestive enzyme 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.
Enzadyne should be administered under the supervision of a licensed medical practitioner.
INDICATIONS AND USAGE:
Enzadyne is an orally administered prescription digestive enzyme 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. -
WARNINGS AND PRECAUTIONS:
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Enzadyne 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.
- DOSAGE AND ADMINISTRATION:
- STORAGE:
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PACKAGE LABEL:
Reserved for Professional Recommendation
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:
Sterling-Knight Pharmaceuticals, LLC
Ripley, MS 38663
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INGREDIENTS AND APPEARANCE
ENZADYNE
proamylipase capsuleProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:69336-403 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:69336-403-30 30 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date dietary supplement 06/05/2019 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color shape size (solid drugs) 22 mm scoring 1 Labeler - Sterling Knight Pharmaceuticals LLC (079556942)