prenate

prenate
SPL v6
SPL
SPL Set ID 1076ba9a-0168-492f-ba9b-99fa02186092
Route
oral
Published
Effective Date 2013-09-27
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
ascorbic acid (85 mg) cholecalciferol (1000 [iU]) .alpha.-tocopherol, dl- (10 [iU]) folic acid (1 mg) pyridoxine (25 mg) cyanocobalamin (12 ug) biotin (500 ug) calcium cation (155 mg) ferrous cation (27 mg) magnesium cation (45 mg) lactic acid (10 mg) doconexent (400 mg)
Inactive Ingredients
gelatin glycerin lecithin, soybean white wax corn oil water fd&c blue no. 1 titanium dioxide fd&c red no. 3

Identifiers & Packaging

Pill Appearance
Imprint: OmegaRx Shape: oval Color: blue Size: 22 mm Score: 1
Marketing Status
unapproved drug other active Since 2013-09-17

Description

Rx postnatal vitamin with probiotics, DHA and chelated iron Rx Only Dietary Supplement


Medication Information

Recent Major Changes

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.

Warnings and Precautions

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

Indications and Usage

INDICATIONS: PRENATE ® Restore is a multivitamin/multimineral fatty acid 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 ® Restore can also be beneficial in improving the nutritional status of women prior to conception.

Dosage and Administration

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

Dosage Forms and Strengths

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.

Contraindications

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

Description

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.

Section 34084-4

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

Section 42229-5

Rx postnatal vitamin with probiotics, DHA and chelated iron

Rx Only Dietary Supplement

Section 42232-9

PRECAUTIONS: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 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.

Section 44425-7

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

Section 51727-6

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

Principal Display Panel 30 Softgel Label

75854-308-30

PRENATE ® Restore



Rx postnatal vitamin with probiotics, DHA

and chelated iron

Rx Only

Dietary Supplement


30 Softgels

Avion

PHARMACEUTICALS


Structured Label Content

Recent Major Changes (34066-1)

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.

Warnings and Precautions (34071-1)

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

Indications and Usage (34067-9)

INDICATIONS: PRENATE ® Restore is a multivitamin/multimineral fatty acid 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 ® Restore can also be beneficial in improving the nutritional status of women prior to conception.

Dosage and Administration (34068-7)

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

Dosage Forms and Strengths (34069-5)

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.

Contraindications (34070-3)

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

Description (34089-3)

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.

Section 34084-4 (34084-4)

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

Section 42229-5 (42229-5)

Rx postnatal vitamin with probiotics, DHA and chelated iron

Rx Only Dietary Supplement

Section 42232-9 (42232-9)

PRECAUTIONS: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 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.

Section 44425-7 (44425-7)

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

Section 51727-6 (51727-6)

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

Principal Display Panel 30 Softgel Label (PRINCIPAL DISPLAY PANEL - 30 Softgel label)

75854-308-30

PRENATE ® Restore



Rx postnatal vitamin with probiotics, DHA

and chelated iron

Rx Only

Dietary Supplement


30 Softgels

Avion

PHARMACEUTICALS


Advanced Ingredient Data


Raw Label Data

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