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Prenara Package Insert

Status:
Prescription (Rx) Facts
Strength:
1000 IU, 100 mg, 750 IU, 1.8 mg, 1.7 mg, 20 mg, 2.5 mg, 1 mg, 0.5 mg, 100 mg, 0.15 mg, 2 mg, 15 mg, 20 mg
Drug class:
Active ingredients:
Similar drugs:

Source: FDA drug labeling via NLM DailyMed · About this document

Prescribing information (package insert) - Prenara

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

About this document

Source: FDA drug labeling via NLM DailyMed · View the label on DailyMed

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Drug information for Prenara

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Calcium, Copper-containing Intrauterine Device, Vitamin A, Vitamin B12, Vitamin B6 Analog, Vitamin C, Vitamin D
Active ingredients Vitamin A 1000 IU, Ascorbic acid 100 mg, Vitamin D 750 IU, Thiamine 1.8 mg, Riboflavin 1.7 mg, Niacinamide 20 mg, Pyridoxine hydrochloride 2.5 mg, Folic acid 1 mg, Cyanocobalamin 0.5 mg, Calcium 100 mg, Iodine 0.15 mg, Copper 2 mg, Magnesium 15 mg, Zinc 20 mg
Dosage form Capsule
Route Oral
Marketing status not in the current FDA NDC Directory
Company (applicant) Sterling-Knight Pharmaceuticals, LLC
FDA approval UNAPPROVED DRUG OTHERUnapproved drug
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
1000 IU, 100 mg, 750 IU, 1.8 mg, 1.7 mg, 20 mg, 2.5 mg, 1 mg, 0.5 mg, 100 mg, 0.15 mg, 2 mg, 15 mg, 20 mg – 30 in 1 bottle NDC 69336-352-30

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.