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NDC 75854-0308-30 PRENATE Restore 10; 85; 500; 155; 1000; 12; 400; 27; 1; 10; 45; 25 [iU]/1; mg/1; ug/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Details

PRENATE Restore 10; 85; 500; 155; 1000; 12; 400; 27; 1; 10; 45; 25 [iU]/1; mg/1; ug/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1

PRENATE Restore is a ORAL CAPSULE, GELATIN COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Avion Pharmaceuticals, LLC. The primary component is .ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; BIOTIN; CALCIUM CARBONATE; CHOLECALCIFEROL; CYANOCOBALAMIN; DOCONEXENT; FERROUS FUMARATE; FOLIC ACID; LACTIC ACID; MAGNESIUM OXIDE; PYRIDOXINE HYDROCHLORIDE.

Product Information

NDC	75854-0308
Product ID	75854-308_b85520e4-ceea-3fd0-e053-2995a90a775d
Associated GPIs	78516024000127
GCN Sequence Number	071464
GCN Sequence Number Description	prenatal vit69/iron/folate6/dh CAPSULE 27-1-400MG ORAL
HIC3	C6F
HIC3 Description	PRENATAL VITAMIN PREPARATIONS
GCN	35265
HICL Sequence Number	040617
HICL Sequence Number Description	PRENATAL VITAMINS NO.69/IRON FUMARATE/FOLATE COMB NO.6/DHA
Brand/Generic	Brand
Proprietary Name	PRENATE Restore
Proprietary Name Suffix	n/a
Non-Proprietary Name	ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, folic acid, pyridoxine hydrochloride, cyanocobalamin, biotin, calcium carbonate, ferrous fumarate, magnesium oxide, lactic acid and doconexent
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	CAPSULE, GELATIN COATED
Route	ORAL
Active Ingredient Strength	10; 85; 500; 155; 1000; 12; 400; 27; 1; 10; 45; 25
Active Ingredient Units	[iU]/1; mg/1; ug/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1
Substance Name	.ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; BIOTIN; CALCIUM CARBONATE; CHOLECALCIFEROL; CYANOCOBALAMIN; DOCONEXENT; FERROUS FUMARATE; FOLIC ACID; LACTIC ACID; MAGNESIUM OXIDE; PYRIDOXINE HYDROCHLORIDE
Labeler Name	Avion Pharmaceuticals, LLC
Pharmaceutical Class	Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inh
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2022-12-31

Package

Package Images

NDC 75854-0308-30 (75854030830)

Pricing Information	N/A
NDC Package Code	75854-308-30
Billing NDC	75854030830
Package	30 CAPSULE, GELATIN COATED in 1 BOTTLE (75854-308-30)
Marketing Start Date	2013-09-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 1076ba9a-0168-492f-ba9b-99fa02186092 Details

SPL UNCLASSIFIED SECTION

Rx postnatal vitamin with probiotics, DHA and chelated iron

Rx Only Dietary Supplement

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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

WARNING

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.

SPL UNCLASSIFIED SECTION

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.

WARNING

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.

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

MANUFACTURED FOR:

Avion Pharmaceuticals, LLC

Alpharetta, GA 30005

1-888-61-AVION

Rev. 0519-01

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.

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.

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

INGREDIENTS AND APPEARANCE

PRENATE RESTORE

ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, folic acid, pyridoxine hydrochloride, cyanocobalamin, biotin, calcium carbonate, ferrous fumarate, magnesium oxide, lactic acid and doconexent capsule, gelatin coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:75854-308
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	85 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	1000 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01)	.ALPHA.-TOCOPHEROL, DL-	10 [iU]
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	25 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	12 ug
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04)	BIOTIN	500 ug
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	155 mg
FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	27 mg
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM OXIDE	45 mg
LACTIC ACID (UNII: 33X04XA5AT) (LACTIC ACID - UNII:33X04XA5AT)	LACTIC ACID	10 mg
DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC)	DOCONEXENT	400 mg

Ingredient Name	Strength
Inactive Ingredients
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
WHITE WAX (UNII: 7G1J5DA97F)
CORN OIL (UNII: 8470G57WFM)
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)

Product Characteristics
Color	blue (dark blue)	Score	no score
Shape	OVAL	Size	22mm
Flavor		Imprint Code	OmegaRx
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:75854-308-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	09/17/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		09/17/2013

Labeler - Avion Pharmaceuticals, LLC (040348516)

Name	Address	ID/FEI	Business Operations
Establishment
Avion Pharmaceuticals, LLC		040348516	manufacture(75854-308)

Revised: 1/2021

Document Id: b85520e4-ceea-3fd0-e053-2995a90a775d

Set id: 1076ba9a-0168-492f-ba9b-99fa02186092

Version: 5

Effective Time: 20210107

Search by Drug Name or NDC

NDC 75854-0308-30 PRENATE Restore 10; 85; 500; 155; 1000; 12; 400; 27; 1; 10; 45; 25 [iU]/1; mg/1; ug/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Details

PRENATE Restore 10; 85; 500; 155; 1000; 12; 400; 27; 1; 10; 45; 25 [iU]/1; mg/1; ug/1; mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1

Product Information

Package

Package Images

NDC 75854-0308-30 (75854030830)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 1076ba9a-0168-492f-ba9b-99fa02186092 Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

WARNING

SPL UNCLASSIFIED SECTION

WARNING

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

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SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 30 Softgel label

INGREDIENTS AND APPEARANCE

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