BACICAP PROBIOTIC: Package Insert and Label Information

BACICAP PROBIOTIC- lactobacillus acidophilus, bifidobacterium animalis lactis, lactobacillus plantarum and lactobacillus paracasei capsule
NATIONAL BIO GREEN SCIENCES LIMITED LIABILTY COMPANY

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

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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

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BACICAP PROBIOTIC
proprietary blend of probiotic bacteria capsule
Product Information
Product Type Item Code (Source) NDC:72678-019
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LACTOBACILLUS ACIDOPHILUS (LACTOBACILLUS ACIDOPHILUS) LACTOBACILLUS ACIDOPHILUS 20000000000 [CFU]
BIFIDOBACTERIUM ANIMALIS LACTIS (BIFIDOBACTERIUM ANIMALIS LACTIS) BIFIDOBACTERIUM ANIMALIS LACTIS 20000000000 [CFU]
LACTOBACILLUS PLANTARUM (LACTOBACILLUS PLANTARUM) LACTOBACILLUS PLANTARUM 20000000000 [CFU]
LACTOBACILLUS PARACASEI (LACTOBACILLUS RHAMNOSUS) LACTOBACILLUS PARACASEI 20000000000 [CFU]
Inactive Ingredients
Ingredient Name Strength
.ALPHA.-CELLULOSE
MALTODEXTRIN
ACETYLLEUCINE, L-
Product Characteristics
Color white (Off-White) Score no score
Shape capsule Size 22mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72678-019-01 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
dietary supplement 06/20/2020
Labeler — NATIONAL BIO GREEN SCIENCES LIMITED LIABILTY COMPANY (967054623)

Revised: 06/2020 NATIONAL BIO GREEN SCIENCES LIMITED LIABILTY COMPANY

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