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Prenate Chewable Package Insert

Status:
Prescription (Rx) Facts
Strength:
500 mg, 7.5 mcg, 50 mg, 12.5 mcg, 400 mcg, 10 mg, 125 mcg, 280 mcg, 25 mg, 600 mcg
Drug class:
Active ingredients:
Similar drugs:

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

Prescribing information (package insert) - Prenate Chewable

DESCRIPTION:

PRENATE CHEWABLE ®is a prescription prenatal/postnatal multivitamin/mineral chocolate chewable tablet. Each tablet is brown and imprinted with “Prenate Chew” on one side and blank on the other.

OTHER INGREDIENTS:Cocoa powder, magnesium stearate, maltodextrin, modified food starch, natural milk chocolate flavor, silica, stearic acid, and sucrose. THIS PRODUCT MAY CONTAIN SOY.

INDICATIONS:

PRENATE CHEWABLE ®is a multivitamin/multimineral dietary supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. PRENATE CHEWABLE ®can also be beneficial in improving the nutritional status of women prior to conception.

CONTRAINDICATIONS:

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

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

PRECAUTIONS:

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B 12is deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

Biotin levels higher than the recommended daily allowance may cause interference with some laboratory tests, including cardiovascular diagnostic test (e.g. troponin) and hormone tests, and may lead to incorrect test results. Tell your healthcare provider about all prescription and over-the-counter medicines, vitamins, and dietary supplements that you take, including biotin. While prescribing this nutritional supplement for pregnant women, nursing mothers or for women prior to conception, their medical condition and other drugs, herbs and/or supplements consumption should be considered.

ADVERSE REACTIONS:

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

DOSAGE AND ADMINISTRATION:

One tablet daily or as directed by a physician.

HOW SUPPLIED:

PRENATE CHEWABLE ®is supplied in child-resistant bottles of 30 tablets (75854-306-30).

The listed product number is not a National Drug Code, but has instead merely been formatted to comply with standard industry practice for pharmacy and insurance computer systems.

Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F). [See USP Controlled Room Temperature.]

THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE.

MANUFACTURED FOR:

Avion Pharmaceuticals, LLC

Alpharetta, GA 30005

1-800-541-4802

L-0159 Rev. 1025-03

*Quatrefolic® is a registered trademark of Gnosis, SpA. Covered by one or more claims of U.S. Patent # 7,947,662 CAS# 1181972-37-1.

About this document

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

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Prenate Chewable

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Blood Coagulation Factor, Calculi Dissolution Agent, Folate Analog, Osmotic Laxative, Phosphate Binder, Vitamin B12, Vitamin B6 Analog, Vitamin D
Active ingredients Calcium carbonate 500 mg, Cholecalciferol 7.5 mcg, Magnesium oxide 50 mg, Boron 12.5 mcg, Folic acid 400 mcg, Pyridoxine hydrochloride 10 mg, Cyanocobalamin 125 mcg, Biotin 280 mcg, Blueberry 25 mg, Levomefolate glucosamine 600 mcg
Dosage form Tablet, chewable
Route Oral
Marketing status not in the current FDA NDC Directory
Company (applicant) Avion Pharmaceuticals, LLC
FDA approval UNAPPROVED DRUG OTHERUnapproved drug
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
500 mg, 7.5 mcg, 50 mg, 12.5 mcg, 400 mcg, 10 mg, 125 mcg, 280 mcg, 25 mg, 600 mcg – 30 in 1 bottle NDC 75854-306-30

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.