ENZADYNE- proamylipase capsule

Enzadyne by

Drug Labeling and Warnings

Enzadyne by is a Other medication manufactured, distributed, or labeled by Sterling Knight Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HEALTH CLAIM:

Enzadyne Capsules Dietary Supplemement

Dispensed by Prescription†

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:

Usual adult dose is 1 capsule daily with or without food. Do not exceed 3 capsules per day.

STORAGE:

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.

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

INGREDIENTS AND APPEARANCE

ENZADYNE 
proamylipase capsule

Product 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)