PRENATE DHA- ascorbic acid, cholecalciferol, .alpha.-tocopherol, dl-, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, magnesium oxide and doconexent capsule, gelatin coated 
Avion Pharmaceuticals, LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Prenate DHA ®

Rx prenatal vitamin & DHA
With

Quatrefolic ®

Rx Only

DESCRIPTION: PRENATE DHA ® is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is blue in color, opaque, and imprinted with “DHA” on one side and blank on the other.

*
Daily Value (DV) not established.
Supplement Facts
Serving Size: 1 Softgel
Amount per Serving:% Daily Value% Daily Value for
Lactating Women
Vitamin C (as ascorbic acid)90 mg150%150%
Vitamin D 3 (as cholecalciferol) 220 IU55%55%
Vitamin E (as dl-alpha tocopherol)10 IU33%33%
Vitamin B 6 (as pyridoxine HCl) 26 mg1300%1040%
Folate
(as 1.1 mg Quatrefolic® ((6S)-5,methyltetrahydrofolate glucosamine salt* CAS 1181972-37-1) molar equivalent to 600 mcg of Folic Acid) (folic acid, USP 400 mcg)
1 mg250%125%
Vitamin B 12 (as cyanocobalamin) 13 mcg217%163%
Calcium (as calcium carbonate)145 mg15%11%
Iron (as ferrous fumarate)28 mg156%156%
Magnesium (as magnesium oxide)50 mg13%11%
Docosahexaenoic Acid (DHA)
(from omega-3 fatty acids from fish oil)
300 mg**

PRENATE DHA® contains fish oil and soy.

OTHER INGREDIENTS: bee’s wax, hydrogenated vegetable oil, soy lecithin, gelatin, glycerin, purified water, titanium dioxide, FD&C Blue #1 and FD&C Red #3.

INDICATIONS: PRENATE DHA ® 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 DHA ® can also be beneficial in improving the nutritional status of women prior to conception.

CONTRAINDICATIONS: PRENATE DHA ® 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 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

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: Before, during and/or after pregnancy, one softgel daily or as directed by a physician.

HOW SUPPLIED: Unit-dose packs of 30 softgels. (75854-302-30).

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.]

MANUFACTURED FOR: Avion Pharmaceuticals, LLC
Atlanta, GA 30350
1-888-61-AVION

*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

PRENATE DHA ® is a registered trademark of Acella Pharmaceuticals, LLC.
Under license from Acella Pharmaceuticals, LLC.
All rights reserved.

Rev. 021412

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

75854-302-30         30 Softgels

Prenate
Rx prenatal vitamin &
DHA ®

with
Quatrefolic ®

• Key vitamins, minerals, and DHA support nutrition

Long lasting stability
Improved bioavailability
High water solubility
Established safety

Quatrefolic ®            Rx Only

Prenate DHA is a registered trademark of Acella Pharmaceuticals, LLC.
*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
Under license from Acella Pharmaceuticals, LLC.
All rights reserved.

PRINCIPAL DISPLAY PANEL - 30 tablets
PRENATE DHA 
ascorbic acid, cholecalciferol, .alpha.-tocopherol, dl-, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, magnesium oxide and doconexent capsule, gelatin coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:75854-302
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID90 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL220 [iU]
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-10 [iU]
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE26 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN13 ug
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE145 mg
FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION28 mg
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE50 mg
DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT300 mg
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX (UNII: 2ZA36H0S2V)  
CORN OIL (UNII: 8470G57WFM)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
Product Characteristics
Colorblue, yellow (opaque) Score2 pieces
ShapeOVALSize24mm
FlavorImprint Code DHA
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75854-302-3030 in 1 CARTON01/31/201204/30/2016
130 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/31/201204/30/2016
Labeler - Avion Pharmaceuticals, LLC (965450542)
Establishment
NameAddressID/FEIBusiness Operations
Avion Pharmaceuticals, LLC965450542manufacture(75854-302)

Revised: 1/2018
 
Avion Pharmaceuticals, LLC