Prenara Capsules Dietary Supplement

Manufacturer
Sterling-Knight Pharmaceuticals, LLC
Effective date
2020-03-03
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:32:31

Label at a glance#

ProductPrenara
Active ingredientVITAMIN A, ASCORBIC ACID, VITAMIN D, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, IODINE, COPPER, MAGNESIUM, ZINC
Label structure11 sections

Indications and uses

Prenara is a prescription dietary supplement for use throughout pregnancy, during the prenatal and postnatal period for both lactating and non-lactating mothers and throughout the childbearing years

Dosage and administration

Usual dose is 1 to 2 capsules daily or as prescribed by licensed medical practitioner.

Storage and handling

Store at controlled room temperature 15°-30°C (59°F-86°F). Keep in cool dry place. Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088. KEEP THIS OUT OF THE REACH OF CHILDREN.

Label contents#

Full prescribing information#

DESCRIPTION:

DESCRIPTION SECTION

Prenara is an orally administered prescription dietary supplement 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.
Prenara is a prescription dietary supplement for use throughout pregnancy, during the prenatal and postnatal period for both lactating and non-lactating mothers and throughout the childbearing years.
Prenara should be administered under the supervision of a licensed medical practitioner.

Each softgel capsule contains:

supplfactssupplfacts

Other Ingredients: Soybean oil, gelatin (bovine), bees wax (yellow), lecithin, glycerin, deionized water, FD&C red #40, FD&C blue #1, titanium dioxide.

INDICATIONS AND USAGE:

INDICATIONS & USAGE SECTION

Prenara is a prescription dietary supplement for use throughout pregnancy, during the prenatal and postnatal period for both lactating and non-lactating mothers and throughout the childbearing years

CONTRAINDICATIONS:

CONTRAINDICATIONS SECTION

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


Prenara 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.

WARNINGS AND PRECAUTIONS:

WARNINGS AND PRECAUTIONS SECTION

This product should be administered with caution in patients with a history of liver disease, jaundice or diabetes mellitus.

Folic acid above 1mg daily may obscure pernicious anemia in that hematologic remission may occur while neurological manifestations remain progressive.

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

ADVERSE REACTION:

ADVERSE REACTIONS SECTION

Allergic sensitization has been reported following both oral and parental administration of folic acid.

DOSAGE AND ADMINISTRATION:

DOSAGE & ADMINISTRATION SECTION

Usual dose is 1 to 2 capsules daily or as prescribed by licensed medical practitioner.

HOW SUPPLIED:

HOW SUPPLIED SECTION

Prenara is supplied as a purple softgel capsules with 352 printed and dispensed in white HDPE plastic bottles of 30ct.

69336-352-30

STORAGE:

STORAGE AND HANDLING SECTION

Store at controlled room temperature 15°-30°C (59°F-86°F). Keep in cool dry place. Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088. KEEP THIS OUT OF THE REACH OF CHILDREN.

SPL UNCLASSIFIED SECTION

Reserved for Professional Recommendation

All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician’s supervision. There are no implied or explicit claims on therapeutic equivalence.

Manufactured for:
Sterling-Knight Pharmaceuticals, LLC
Ripley, MS 38663


Item 35230                  Rev. 0320-1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Prenara Label

prenaralabelprenaralabel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Prenara Carton

prenaracartonprenaracarton

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASCORBIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CALCIUM Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230427
CHOLECALCIFEROL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
COPPER Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CYANOCOBALAMIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310
VITAMIN A Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c599c4a0-705d-4ebb-ab1f-977af038f96aProduct name120251124
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69336-352-302022-01-28C16284748780-1d6a99b39-8743-a426-e053-dadaa90af4c2Prenara Capsules Dietary Supplement

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69336-352-30Prenara30 in 1 BOTTLECAPSULE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69336-352PRENARA CAPSULE [STERLING-KNIGHT PHARMACEUTICALS, LLC]1Legacy NDC, 1 package rows20200310_bb306403-27d2-452b-bc91-fbf033d22d10.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69336-352-30EA - Each69336-3520ffa9208-62ae-463c-9fe1-03263109227712020-05-08

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69336-35269336-352-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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
f6d38c4c-309f-4a20-8e7b-126bfed0feb9bb306403-27d2-452b-bc91-fbf033d22d102020-03-03Warnings, Adverse reactionsExact identifier
spl id: f6d38c4c-309f-4a20-8e7b-126bfed0feb9
spl set id: bb306403-27d2-452b-bc91-fbf033d22d10

Reported adverse events (FAERS/openFDA)#

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