Label: PRODIGEN- lactobacillus acidophilus capsule
- NHRIC Code(s): 69336-402-30
- Packager: Sterling Knight Pharmaceuticals LLC
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Drug Label Information
Updated July 31, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- HEALTH CLAIM:
-
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 38663Item 40230
Rev. 0418-1 - STORAGE:
- PACKAGE LABEL:
-
INGREDIENTS AND APPEARANCE
PRODIGEN
lactobacillus acidophilus capsuleProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:69336-402 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LACTOBACILLUS ACIDOPHILUS (UNII: 1PRR1V42V5) (LACTOBACILLUS ACIDOPHILUS - UNII:1PRR1V42V5) LACTOBACILLUS ACIDOPHILUS 16000000000 [CFU] BIFIDOBACTERIUM ANIMALIS LACTIS (UNII: 5307V7XW8I) (BIFIDOBACTERIUM ANIMALIS LACTIS - UNII:5307V7XW8I) BIFIDOBACTERIUM ANIMALIS LACTIS 15000000000 [CFU] Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) MAGNESIUM STEARATE (UNII: 70097M6I30) HYDRATED SILICA (UNII: Y6O7T4G8P9) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:69336-402-30 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date dietary supplement 04/27/2018 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color shape size (solid drugs) 16 mm scoring 1 Labeler - Sterling Knight Pharmaceuticals LLC (079556942)
