Label: BACICAP PROBIOTIC- proprietary blend of probiotic bacteria capsule
- NHRIC Code(s): 72678-019-01
- Packager: NATIONAL BIO GREEN SCIENCES LIMITED LIABILTY COMPANY
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Drug Label Information
Updated June 20, 2020
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STATEMENT OF IDENTITY
BACICAP Probiotic Dietary Supplement
Dispensed by Prescription
Amount Per Serving
%DV
Proprietary blend of Probiotic Bacteria;
MAKTREK (Bi-Pass Technology)
20 Billion
*
*Daily Values (DV) not established
OTHER INGREDIENTS: Cellulose (Vegetable Capsule), Rice Maltodextrin, L-Leucine
BACICAP 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.
BACICAP should be administered under the supervision of a licensed medical practitioner.
BACICAP is manufactured in accordance with Current Good Manufacturing Practice for foods, using ingredients that have been approved by the U.S. Food and Drug Administration (FDA) as food additives or are Generally Recognized as Safe (GRAS) for their intended use.
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DOSAGE
Usual adult dose is 1 capsule once or twice daily, or as prescribed by a licensed medical practitioner.
If you are pregnant or nursing, ask a healthcare professional.
BACICAP should be administered under the supervision of a licensed medical practitioner.
DIRECTIONS FOR USE: Take as directed by a healthcare professional.
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SAFE HANDLING
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
BACICAP capsules 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.
KEEP OUT OF REACH OF CHILDREN
STORAGE
Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature.]
HOW SUPPLIED HEALTH CLAIM
BACICAP, Probiotic Dietary Supplement
Capsules are off-white in color, each bottle contains 30 Capsules 72678-019-01*
Manufactured in USA for:
NATIONAL BIO GREEN SCIENCES LIMITED LIABILTY COMPANY
Branchburg, NJ 08876
Rev. 3/2020* NATIONAL BIO GREEN SCIENCES LIMITED LIABILTY COMPANY does not represent these product codes to be National Drug Codes (NDC). Product codes are formatted according to standard industry practice, to meet the formatting requirement by pedigree reporting and supply-chain control including pharmacies.
† The most appropriate way to ensure pedigree reporting consistent with these regulatory guidelines and safety monitoring is to dispense this product by prescription. This is not an Orange Book product. This product may be administered only under a physician’s supervision and all prescriptions using this product shall be pursuant to state statutes as applicable. The ingredients, indication or claims of this product are not to be construed to be drug claims.
- PRINCIPAL DISPLAY PANEL - 30 CAPSULES BOTTLE LABEL
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INGREDIENTS AND APPEARANCE
BACICAP PROBIOTIC
proprietary blend of probiotic bacteria capsuleProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:72678-019 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LACTOBACILLUS ACIDOPHILUS (UNII: 1PRR1V42V5) (LACTOBACILLUS ACIDOPHILUS - UNII:1PRR1V42V5) LACTOBACILLUS ACIDOPHILUS 20000000000 [CFU] BIFIDOBACTERIUM ANIMALIS LACTIS (UNII: 5307V7XW8I) (BIFIDOBACTERIUM ANIMALIS LACTIS - UNII:5307V7XW8I) BIFIDOBACTERIUM ANIMALIS LACTIS 20000000000 [CFU] LACTOBACILLUS PLANTARUM (UNII: QFC21096ON) (LACTOBACILLUS PLANTARUM - UNII:QFC21096ON) LACTOBACILLUS PLANTARUM 20000000000 [CFU] LACTOBACILLUS PARACASEI (UNII: N1G291SC6Q) (LACTOBACILLUS RHAMNOSUS - UNII:9601IVB87J) LACTOBACILLUS PARACASEI 20000000000 [CFU] Inactive Ingredients Ingredient Name Strength .ALPHA.-CELLULOSE (UNII: I355QGZ19A) MALTODEXTRIN (UNII: 7CVR7L4A2D) ACETYLLEUCINE, L- (UNII: E915HL7K2O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:72678-019-01 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date dietary supplement 06/20/2020 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color shape size (solid drugs) 22 mm scoring 1 Labeler - NATIONAL BIO GREEN SCIENCES LIMITED LIABILTY COMPANY (967054623)