Inflamex

Manufacturer
PureTek Corporation
Effective date
2024-06-12
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 21:05:23

Label at a glance#

ProductInflamex
Active ingredientBLACK PEPPER, NIACINAMIDE, GARLIC, TURMERIC, LEVOMEFOLATE CALCIUM
Label structure10 sections

Dosage and administration

One (1) lnflamex ™ capsule daily or as directed by a licensed healthcare practitioner. Do not administer to children under the age of 12.

Storage and handling

Do not use if bottle seal is broken. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Label contents#

Full prescribing information#

DESCRIPTION:

DESCRIPTION SECTION

lnflamex™ is a unique formulation of selected natural ingredients such as Turmeric, Black Pepper, Garlic and Proprietary Extract Blend combined with Niacin and Folate. This potent blend is designed to support your body's response to inflammation and its natural healing processes.

Each capsule contains:

Niacin (as Niacinamide) ....……………………………….…......25 mg
Folate (as L-5-Methyltetrahydrofolate calcium salt) ..........1700 mcg DFE
(1000 mcg of L-5-Methylfolate)
Turmeric Root Extract……………………………….…………100 mg
Garlic Bulb Extract……………………………….…………….. 10 mg
Pepper Seed Extract……………………………….…………….. 5 mg


Proprietary Extract Blend ………………………….…………. 400 mg

Other Ingredients:

SPL UNCLASSIFIED SECTION

Magnesium Stearate, Microcrystalline Cellulose, Oryza Sativa (Rice) Starch, Vegetable Capsule.

Contraindications:

CONTRAINDICATIONS SECTION

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. lnflamex™ is contraindicated in patients with gastrointestinal conditions, such as gastric ulcers or gastroesophageal reflux disease (GERD), as they may experience irritation or worsening of symptoms due to the presence of ingredients like garlic and black pepper. Patients with blood clotting disorders or who are on anticoagulant therapy should use caution when consuming high doses of ingredients like garlic, turmeric, and black pepper, as they may have mild blood-thinning effects.

Warnings:

WARNINGS SECTION

Tell your doctor if you have: kidney problems, thyroid disease. This medication should be used as directed during pregnancy or while breast-feeding. Consult your doctor. Administration of folate alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B12 is deficient.

Precautions:

PRECAUTIONS SECTION

Folate in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive. There is a potential danger in administering folate to patients with undiagnosed anemia since folate may obscure the diagnosis of pernicious anemia by alleviating the hematologic manifestations of the disease while allowing the neurologic complications to progress. This may result in severe nervous system damage before the correct diagnosis is made. The patient's medical conditions and consumption of other drugs, herbs, and/or supplements should be considered.

Pregnancy and Lactation:

PREGNANCY SECTION

Not recommended for use during pregnancy or lactation without consulting with a healthcare professional.

For use on the order of a licensed healthcare practitioner.
If a patient experiences any side effects, call your doctor. To report side effects, call PureTek Corporation at 1-877-921-7873 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Adverse Reactions:

ADVERSE REACTIONS SECTION

Allergic reactions to any of the ingredients can occur, ranging from mild skin irritation to severe anaphylaxis in rare cases. Allergic sensitization has been reported following both oral and parenteral administration of folate.


Niacinamide, a form of niacin, may cause flushing, itching, and tingling sensations in some individuals, particularly when taken in higher doses. This effect is usually harmless but can be uncomfortable. Some individuals may experience gastrointestinal symptoms such as nausea, bloating, or diarrhea, especially when consuming higher doses of certain ingredients like garlic and black pepper. Certain ingredients in the product, such as garlic and black pepper, may interact with medications. Garlic may potentiate the effects of anticoagulant medications, while black pepper may affect the metabolism of certain drugs.

Dosage and Administration:

DOSAGE & ADMINISTRATION SECTION

One (1) lnflamex ™ capsule daily or as directed by a licensed healthcare practitioner. Do not administer to children under the age of 12.

How Supplied:

HOW SUPPLIED SECTION

lnflamex™ are light orange powder with black specks, in vegan hard shell capsules. One bottle contains 30 capsules (NDC 59088-191-54). Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure.

Storage:

STORAGE AND HANDLING SECTION

Do not use if bottle seal is broken.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Inflamex™

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Manufactured in the USA by:

PureTek Corporation
Panorama City, CA 91402
For questions or information
call toll-free: 877-921-7873

labellabel

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BLACK PEPPER Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GARLIC Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
LEVOMEFOLIC ACID Pharmacologic Class Indexing1Indexing - Pharmacologic Class20230428

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ddff2484-d547-4e6a-bacd-95eef7e31c64Product name220180807
90854981-3820-4bc4-a1d3-666ec508941cProduct name220180214

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-191-54Inflamex30 in 1 BOTTLECAPSULE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-191INFLAMEX (MULTIVITAMIN) CAPSULE [PURETEK CORPORATION]1Current NDC, 1 package rows20240616_1859a102-9152-018d-e063-6394a90a925f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-191-54EA - Each59088-191f4d69cfe-02cd-48b0-af10-5341c2395f5112024-07-12

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59088-19159088-191-54

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
InflamexMULTIVITAMINPureTek Corporation1859a102-9152-018d-e063-6394a90a925f2024-06-12Warnings, Adverse reactionsExact identifier
ndc (package): 59088-191-54
ndc (product): 59088-191
ndc11 (package): 59088019154
spl id: 1859a102-9152-018d-e063-6394a90a925f
spl set id: 1859a102-9152-018d-e063-6394a90a925f

Reported adverse events (FAERS/openFDA)#

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