PRIMACARE- calcium ascorbate dihydrate, cholecalciferol, dl-a tocopheryl acetate, riboflavin, niacinamide, folate, biotin, calcium, ferrous asparto glycinate, potassium iodide, magnesium oxide, zinc bisglycinate chelate, alpha linoleic acid, dha, epa pill

PrimaCare by

Drug Labeling and Warnings

PrimaCare by is a Prescription medication manufactured, distributed, or labeled by Avion Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

DESCRIPTION: PrimaCare™ is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is purple in color and imprinted with “PRIMA” on one side and blank on the other.'

PrimaCare™ contains flaxseed oil, fish oil and soy.

OTHER INGREDIENTS: Gelatin capsule (bovine gelatin, sorbitol, glycerin, purified water, titanium dioxide, FD&C Red #40, caramel coloring, FD&C Blue #1), yellow beeswax and soy lecithin.

INDICATIONS & USAGE

INDICATIONS: PrimaCare™ is a multivitamin/multimineral fatty acid dietary supplement indicated for use in improving the nutritional status of omen throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers.

CONTRAINDICATIONS

CONTRAINDICATIONS: PrimaCare™ is contraindicated in patients with a known hypersensitivity to any of the ingredients.

BOXED WARNING

(What is this?)

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 n patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding.

PRECAUTIONS

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.

BOXED WARNING

(What is this?)

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

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

DOSAGE & ADMINISTRATION

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

HOW SUPPLIED

HOW SUPPLIED: Bottles of 30 softgels (75854-322-30). 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 AND HANDLING

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.

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

SPL UNCLASSIFIED SECTION

MANUFACTURED FOR:
Avion Pharmaceuticals, LLC
Alpharetta, Georgia 30022 1-888-61-AVION
Rev. 1016-06 AV-427

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

INGREDIENTS AND APPEARANCE

PRIMACARE 
calcium ascorbate dihydrate, cholecalciferol, dl-a tocopheryl acetate, riboflavin, niacinamide, folate, biotin, calcium, ferrous asparto glycinate, potassium iodide, magnesium oxide, zinc bisglycinate chelate, alpha linoleic acid, dha, epa pill

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 75854-322
Route of Administration	oral

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM ASCORBATE (UNII: 183E4W213W) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	25 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	1000 [iU]
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1)	ALPHA-TOCOPHEROL ACETATE	15 [iU]
riboflavin (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	riboflavin	1.5 mg
niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	niacinamide	10 mg
PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	50 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
Biotin (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04)	Biotin	1 mg
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	100 mg
potassium iodide (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q)	IODIDE ION	150 ug
magnesium oxide (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM CATION	50 mg
ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS)	ZINC	15 mg
LINOLEIC ACID (UNII: 9KJL21T0QJ) (LINOLEIC ACID - UNII:9KJL21T0QJ)	LINOLEIC ACID	50 mg
OMEGA-3 FATTY ACIDS (UNII: 71M78END5S) (OMEGA-3 FATTY ACIDS - UNII:71M78END5S)	OMEGA-3 FATTY ACIDS	420 mg

Inactive Ingredients
Ingredient Name	Strength
FERROUS ASPARTO GLYCINATE (UNII: H7426RGB3L)	30 mg
GELATIN (UNII: 2G86QN327L)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CARNAUBA WAX (UNII: R12CBM0EIZ)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)

Product Characteristics
Color	purple	Score	no score
Shape	capsule	Size	24mm
Flavor		Imprint Code	PRIMA
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75854-322-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/23/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/23/2017

Labeler - Avion Pharmaceuticals, LLC (965450542)

Registrant - Avion Pharmaceuticals, LLC (965450542)

Establishment
Name	Address	ID/FEI	Business Operations
Avion Pharmaceuticals, LLC		965450542	manufacture(75854-322)