PrimaCare

PRIMACARE- calcium ascorbate, cholecalciferol, alpha-tocopherol acetate, riboflavin, niacinamide, pyridoxine, folic acid, biotin, calcium carbonate, potassium iodide, magnesium oxide, zinc, linoleic acid and omega-3 fatty acids pill
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.

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.’

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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: 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: PrimaCare™ 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 n 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 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: 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: 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: 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.

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.

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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCIUM ASCORBATE (ASCORBIC ACID) ASCORBIC ACID 25 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 1000 [iU]
ALPHA-TOCOPHEROL ACETATE (.ALPHA.-TOCOPHEROL) ALPHA-TOCOPHEROL ACETATE 15 [iU]
riboflavin (RIBOFLAVIN) riboflavin 1.5 mg
niacinamide (NIACINAMIDE) niacinamide 10 mg
PYRIDOXINE (PYRIDOXINE) PYRIDOXINE 50 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
Biotin (BIOTIN) Biotin 1 mg
CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CARBONATE 100 mg
potassium iodide (IODIDE ION) IODIDE ION 150 ug
magnesium oxide (MAGNESIUM CATION) MAGNESIUM CATION 50 mg
ZINC (ZINC) ZINC 15 mg
LINOLEIC ACID (LINOLEIC ACID) LINOLEIC ACID 50 mg
OMEGA-3 FATTY ACIDS (OMEGA-3 FATTY ACIDS) OMEGA-3 FATTY ACIDS 420 mg
Inactive Ingredients
Ingredient Name Strength
FERROUS ASPARTO GLYCINATE 30 mg
GELATIN
SORBITOL
GLYCERIN
WATER
TITANIUM DIOXIDE
FD&C RED NO. 40
FD&C BLUE NO. 1
CARNAUBA WAX
LECITHIN, SOYBEAN
Product Characteristics
Color purple Score no score
Shape capsule Size 24mm
Flavor Imprint Code PRIMA
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:75854-322-30 30 PILL in 1 BOTTLE None
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 Operations
Avion Pharmaceuticals, LLC 965450542 manufacture (75854-322)

Revised: 03/2017 Avion Pharmaceuticals, LLC

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