Label: PROVAD- bacillus subtilus capsule
- NHRIC Code(s): 69176-680-30
- Packager: TMIG Inc
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Drug Label Information
Updated February 14, 2019
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DESCRIPTION
Provad is an orally administered prescription probiotic
Prodigen should be administered under the supervision of a licensed medical practitioner.
PLEASE NOTE: The product label name of "30 Billion-Biotic" is a descriptive marketing name only and not intended to represent the exact contents of the capsules. The actual product contains 29.3 Billion CFU. Please refer to details below for actual ingrediants and amounts. - HEALTH CLAIM
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WARNINGS AND PRECAUTIONS
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Provad 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.
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DOSAGE AND ADMINISTRATION
Usual adult dose is 1 capsule daily with or without food or as prescribed by your doctor.
INDICATIONS AND USAGE
Provad 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.
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HOW SUPPLIED:
Provad is supplied as apsules dispensed in 180cc plastic bottles of 30ct.
69176-680-30
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 and distributed by:
TMIG INC, Marietta, GA 30062 - STORAGE:
- PACKAGE LABEL:
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INGREDIENTS AND APPEARANCE
PROVAD
bacillus subtilus capsuleProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:69176-680 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACILLUS SUBTILIS (UNII: 8CF93KW41W) (BACILLUS SUBTILIS - UNII:8CF93KW41W) BACILLUS SUBTILIS 26000000000 [CFU] BACILLUS COAGULANS (UNII: ISK1LOY57E) (BACILLUS COAGULANS - UNII:ISK1LOY57E) BACILLUS COAGULANS 1300000000 [CFU] LACTOBACILLUS ACIDOPHILUS (UNII: 1PRR1V42V5) (LACTOBACILLUS ACIDOPHILUS - UNII:1PRR1V42V5) LACTOBACILLUS ACIDOPHILUS 250000000 [CFU] BIFIDOBACTERIUM ANIMALIS LACTIS (UNII: 5307V7XW8I) (BIFIDOBACTERIUM ANIMALIS LACTIS - UNII:5307V7XW8I) BIFIDOBACTERIUM ANIMALIS LACTIS 250000000 [CFU] BIFIDOBACTERIUM LONGUM (UNII: 831AQW699W) (BIFIDOBACTERIUM LONGUM - UNII:831AQW699W) BIFIDOBACTERIUM LONGUM 250000000 [CFU] LACTOBACILLUS RHAMNOSUS (UNII: 9601IVB87J) (LACTOBACILLUS RHAMNOSUS - UNII:9601IVB87J) LACTOBACILLUS RHAMNOSUS 250000000 [CFU] LACTOBACILLUS SALIVARIUS (UNII: 7A4S6N2EG2) (LACTOBACILLUS SALIVARIUS - UNII:7A4S6N2EG2) LACTOBACILLUS SALIVARIUS 250000000 [CFU] LACTOBACILLUS CASEI (UNII: SA940P2U00) (LACTOBACILLUS CASEI - UNII:SA940P2U00) LACTOBACILLUS CASEI 250000000 [CFU] BIFIDOBACTERIUM BREVE (UNII: L07O8T40TE) (BIFIDOBACTERIUM BREVE - UNII:L07O8T40TE) BIFIDOBACTERIUM BREVE 250000000 [CFU] LACTOBACILLUS PLANTARUM (UNII: QFC21096ON) (LACTOBACILLUS PLANTARUM - UNII:QFC21096ON) LACTOBACILLUS PLANTARUM 250000000 [CFU] Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:69176-680-30 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date dietary supplement 02/01/2019 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color shape size (solid drugs) 16 mm scoring 1 Labeler - TMIG Inc (036572986)