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Prenara

Generic name: vitamin a, ascorbic acid, vitamin d, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium, iodine, copper, magnesium and zinc
Dosage form: capsule
Drug class: Iron products, Vitamin and mineral combinations

Medically reviewed by Drugs.com. Last updated on Mar 1, 2020.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

DESCRIPTION:

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:

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:

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:

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:

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:

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

DOSAGE AND ADMINISTRATION:

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

HOW SUPPLIED:

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

69336-352-30

STORAGE:

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.

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

Prenara Label

Prenara Carton

Prenara
Prenara capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:69336-352
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VITAMIN A (VITAMIN A) VITAMIN A 1000 [iU]
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 100 mg
VITAMIN D (CHOLECALCIFEROL) VITAMIN D 750 [iU]
THIAMINE (THIAMINE ION) THIAMINE 1.8 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 1.7 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 20 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 2.5 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 0.5 mg
CALCIUM (CALCIUM) CALCIUM 100 mg
IODINE (IODINE) IODINE 0.15 mg
COPPER (COPPER) COPPER 2 mg
MAGNESIUM (MAGNESIUM) MAGNESIUM 15 mg
ZINC (ZINC) ZINC 20 mg
Product Characteristics
Color purple Score no score
Shape capsule Size 11mm
Flavor Imprint Code 352
Contains
Packaging
# Item Code Package Description
1 NDC:69336-352-30 30 CAPSULE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/09/2020
Labeler - Sterling-Knight Pharmaceuticals, LLC (079556942)
Establishment
Name Address ID/FEI Operations
Sterling-Knight Pharmaceuticals, LLC 079556942 manufacture(69336-352), label(69336-352)
Sterling-Knight Pharmaceuticals, LLC