Prodigen: Package Insert and Label Information

PRODIGEN- lactobacillus acidophilus and bifidobacterium animalis lactis capsule
Sterling Knight Pharmaceuticals LLC

HEALTH CLAIM:

Prodigen Capsules Dietary Supplemement

Dispensed by Prescription†

suppfacts
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DESCRIPTION

Prodigen is an orally administered prescription probiotic 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.

Prodigen should be administered under the supervision of a licensed medical practitioner.

WARNINGS AND PRECAUTIONS

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

Prodigen 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.

INDICATIONS AND USAGE

Prodigen is an orally administered prescription probiotic 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.

HOW SUPPLIED:

Prodigen is supplied as clear capsules dispensed in HDPE plastic bottles of 30ct.

69336-402-30

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

Item 40230
Rev. 0418-1

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:

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PRODIGEN
lactobacillus acidophilus capsule
Product Information
Product Type Item Code (Source) NDC:69336-402
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LACTOBACILLUS ACIDOPHILUS (LACTOBACILLUS ACIDOPHILUS) LACTOBACILLUS ACIDOPHILUS 16000000000 [CFU]
BIFIDOBACTERIUM ANIMALIS LACTIS (BIFIDOBACTERIUM ANIMALIS LACTIS) BIFIDOBACTERIUM ANIMALIS LACTIS 15000000000 [CFU]
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
HYDRATED SILICA
Product Characteristics
Color white Score no score
Shape capsule Size 16mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69336-402-30 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
dietary supplement 04/27/2018
Labeler — Sterling Knight Pharmaceuticals LLC (079556942)

Revised: 07/2018 Sterling Knight Pharmaceuticals LLC

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