BACICAP PROBIOTIC- proprietary blend of probiotic bacteria capsule

BACICAP PROBIOTIC by

Drug Labeling and Warnings

BACICAP PROBIOTIC by is a Other medication manufactured, distributed, or labeled by NATIONAL BIO GREEN SCIENCES LIMITED LIABILTY COMPANY. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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.

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

INGREDIENTS AND APPEARANCE

BACICAP PROBIOTIC 
proprietary blend of probiotic bacteria capsule

Product 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)