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PRENATE Restore Package Insert

Status:
Prescription (Rx) Boxed warning Facts
Strength:
85 mg, 1000 IU, 10 IU, 1 mg, 25 mg, 12 mcg, 500 mcg, 160 mg, 27 mg, 45 mg, 10 mg, 400 mg
Drug class:
Active ingredients:
Similar drugs:

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

Prescribing information (package insert) - PRENATE Restore

Rx postnatal vitamin with probiotics, DHA and chelated iron

Rx Only Dietary Supplement

DESCRIPTION: PRENATE ® Restore is a prescription postnatal vitamin dietary supplement that contains probiotics, DHA and advanced calcium. Each dark blue softgel is imprinted with Omega Rx on one side and blank on the other.

OTHER INGREDIENTS: Beeswax, palm shortening, and soy lecithin. Gelatin capsule (FD&C Blue #1, FD&C Red #3, gelatin, glycerin, purified water, sorbitol and titanium dioxide).

INDICATIONS: PRENATE ® Restore is a multivitamin/multimineral fatty acid dietary supplement indicated for use in improving the nutritional status of women during the postnatal period for both lactating and nonlactating mothers.

CONTRAINDICATIONS: PRENATE ® Restore is contraindicated in patients with a known hypersensitivity to any of the ingredients.

WARNING: Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding.

PRECAUTIONS: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B 12 is 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.

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

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

DOSAGE AND ADMINISTRATION: One softgel daily, or as directed by a physician.

HOW SUPPLIED: Bottles of 30 softgels (75854-308-30). The listed product number is not a National Drug Code. Instead, Avion Pharmaceuticals has assigned a product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and healthcare insurance computer systems.

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

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

MANUFACTURED FOR:

Avion Pharmaceuticals, LLC

Alpharetta, GA 30005

1-888-61-AVION

L-0169 Rev. 0325-02

Formical ® is a registered trademark of Nephro-Tech 1, LLC, covered by one or more claims of U.S. Patent No. 6,528,542.

Sumalate ® is a registered trademark of Albion Laboratories, Inc., covered by one or more claims of U.S. Patent Nos. 5,516,925, 6,716,814, 8,007,846 and 8,425,956.

LactoSpore ® is a registered trademark of Sabinsa Corporation.

PRENATE ® is a registered trademark of Avion Pharmaceuticals, LLC. All rights reserved.

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.

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 Restore

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Boxed warning Yes – this drug has a boxed warning (also called a black box warning), the strongest warning of the FDA.
Drug class Calcium, Calculi Dissolution Agent, Osmotic Laxative, Vitamin B12, Vitamin B6 Analog, Vitamin C, Vitamin D
Active ingredients Ascorbic acid 85 mg, Cholecalciferol 1000 IU, Alpha-tocopherol acetate, DL- 10 IU, Folic acid 1 mg, Pyridoxine hydrochloride 25 mg, Cyanocobalamin 12 mcg, Biotin 500 mcg, Calcium 160 mg, Iron 27 mg, Magnesium oxide 45 mg, Lactic acid 10 mg, Doconexent 400 mg
Dosage form Capsule, gelatin coated
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
85 mg, 1000 IU, 10 IU, 1 mg, 25 mg, 12 mcg, 500 mcg, 160 mg, 27 mg, 45 mg, 10 mg, 400 mg – 30 in 1 bottle NDC 75854-308-30

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.