PROMEROL- probiotic capsule 
PureTek Corporation

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Promerol 56 ct

STATEMENT OF IDENTITY

Promerol™

image description
Other Ingredients: Potato Starch, Magnesium Stearate, Ascorbic Acid, Vegetable Capsule (Hydroxypropylmethylcellulose).
Promerol™ 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.
Promerol™ should be adinistered under the supervision of a licensed medical practitioner.
Promerol™ 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 one capsule once daily, or as prescribed by a licensed medical practitioner.
If you are pregnant or nursing, ask a healthcare professional.

SAFE HANDLING

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Promerol™ 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° to 25°C (68° to 77°F).
Keep in a cool dry place.

HOW SUPPLIED HEALTH CLAIM

Promerol™, Probiotic 

Dietary Supplement

NHRIC: 59088-174 *

Bottles contain 56 Capsules

Manufactured in Canada and
Distributed in the USA by:
PureTek Corporation
Panorama City, CA 91402
Questions? Call toll-free:
1-877-921-7873

*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.

Promerol™

image description

PROMEROL 
probiotic capsule
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:59088-174
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LACTOBACILLUS ACIDOPHILUS (UNII: 1PRR1V42V5) (LACTOBACILLUS ACIDOPHILUS - UNII:1PRR1V42V5) LACTOBACILLUS ACIDOPHILUS16000000000 [CFU]
BIFIDOBACTERIUM ANIMALIS LACTIS (UNII: 5307V7XW8I) (BIFIDOBACTERIUM ANIMALIS LACTIS - UNII:5307V7XW8I) BIFIDOBACTERIUM ANIMALIS LACTIS15000000000 [CFU]
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:59088-174-5756 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT12/29/2020
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
color
shape
size (solid drugs)25 mm
scoring1
Labeler - PureTek Corporation (785961046)

Revised: 2/2021
Document Id: 9b36f284-15b6-499b-931e-56cf40252164
Set id: 22293b96-ece9-491c-bf88-8aeb01bd2709
Version: 5
Effective Time: 20210218
 
PureTek Corporation