Promerol

Manufacturer
PureTek Corporation
Effective date
2021-02-18
Label type
DIETARY SUPPLEMENT
Version
5
Source
full-release
Hydrated at
2026-06-01 02:49:53

Label at a glance#

ProductPromerol
Active ingredientLACTOBACILLUS ACIDOPHILUS, BIFIDOBACTERIUM ANIMALIS LACTIS
Label structure6 sections

Label contents#

Full prescribing information#

STATEMENT OF IDENTITY

STATEMENT OF IDENTITY SECTION

Promerol™

image descriptionimage 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

DOSAGE & ADMINISTRATION SECTION

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

PRECAUTIONS SECTION

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

HEALTH CLAIM SECTION

Store at 20° to 25°C (68° to 77°F).
Keep in a cool dry place.

HOW SUPPLIED HEALTH CLAIM

HEALTH CLAIM SECTION

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™

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-174-57Promerol56 in 1 BOTTLECAPSULE565

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-174PROMEROL (PROBIOTIC) CAPSULE [PURETEK CORPORATION]51 package rows20210220_22293b96-ece9-491c-bf88-8aeb01bd2709.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-174-57EA - Each59088-174a607a7ab-ce28-45ac-83e9-543d17a08d0b12021-02-05

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59088-17459088-174-57

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.