Prenate DHA

Basic Information

Product Label

Product label for Prenate DHA
Full Name: Prenate DHA
Brand: Avion Pharmaceuticals none
Product Type: Other Combinations
Physical State: Softgel Capsule
Product Version Code: Rev. 021412

Contact Information

MANUFACTURED FOR

Name: Avion Pharmaceuticals, LLC
Address:Atlanta, GA, 30350
Phone: 1-888-612-8466
Types: Distributor

To learn more about your pregnancy, go to

Types: Other

Product Details

Net Contents

N/A(0 Not Present)

Serving Sizes

Unit:Softgel(s)
Quantity:1 - 1
Daily Servings:1 - 1

Target Groups

Pregnant WomenAdult Female (18 - 50 Years)Lactating

Ingredients & Nutrition

Calcium

mineral

Notes: Calcium (Form: as Calcium Carbonate)

Forms:
  • Calcium Carbonate
Amount: 145 mg
Serving Size: 1 Softgel(s)
Adults and children 4 or more years of age: 15%
Pregnant and Lactating: 11%

Group: Calcium

Notes: Docosahexaenoic Acid (Form: from Omega-3 Fatty Acids (Form: from Fish Oil)) (Alt. Name: DHA)

Forms:
  • Fish Oil
Amount: 300 mg
Serving Size: 1 Softgel(s)
Pregnant and Lactating: % (Daily value (DV) not established.)
Adults and children 4 or more years of age: % (Daily value (DV) not established.)

Group: DHA (Docosahexaenoic Acid)

Also known as: DHA

Folate

vitamin
Amount: 1 mg
Serving Size: 1 Softgel(s)
Adults and children 4 or more years of age: 250%
Pregnant and Lactating: 125%

Group: Vitamin B9 (Folate)

Iron

mineral

Notes: Iron (Form: as Ferrous Fumarate)

Forms:
  • as Ferrous Fumarate
Amount: 28 mg
Serving Size: 1 Softgel(s)
Adults and children 4 or more years of age: 156%
Pregnant and Lactating: 156%

Group: Iron

Magnesium

mineral

Notes: Magnesium (Form: as Magnesium Oxide)

Forms:
  • as Magnesium Oxide
Amount: 50 mg
Serving Size: 1 Softgel(s)
Adults and children 4 or more years of age: 13%
Pregnant and Lactating: 11%

Group: Magnesium

Notes: Vitamin B12 (Form: as Cyanocobalamin)

Forms:
  • Cyanocobalamin
Amount: 13 mcg
Serving Size: 1 Softgel(s)
Adults and children 4 or more years of age: 217%
Pregnant and Lactating: 163%

Group: Vitamin B12

UNII Code: 8406EY2OQA

Vitamin B6

vitamin

Notes: Vitamin B6 (Form: as Pyridoxine HCl)

Forms:
  • Pyridoxine Hydrochloride
Amount: 26 mg
Serving Size: 1 Softgel(s)
Adults and children 4 or more years of age: 1300%
Pregnant and Lactating: 1040%

Group: Vitamin B6

Vitamin C

vitamin
Forms:
  • Ascorbic Acid
Amount: 90 mg
Serving Size: 1 Softgel(s)
Adults and children 4 or more years of age: 150%
Pregnant and Lactating: 150%

Group: Vitamin C (unspecified)

Vitamin D3

vitamin
Forms:
  • Cholecalciferol
Amount: 220 IU
Serving Size: 1 Softgel(s)
Adults and children 4 or more years of age: 55%
Pregnant and Lactating: 55%

Group: Vitamin D

Also known as: Cholecalciferol, Vitashine vegan Cholecaciferol, Vitashine, Vitashine D3 Cholecalciferol, Vitashine vegan Cholecalciferol, natural Cholecalciferol, plant-based Cholecalciferol, vegan Cholecalciferol, fermented Cholecalciferol, Vitashine D3

UNII Code: 1C6V77QF41

Vitamin E

vitamin

Notes: Vitamin E (Form: as DL-Alpha Tocopherol)

Forms:
  • DL-Alpha-Tocopherol
Amount: 10 IU
Serving Size: 1 Softgel(s)
Adults and children 4 or more years of age: 33%
Pregnant and Lactating: 33%

Group: Vitamin E

Also known as: Sun E 900, Naturall-e, Sunvitol, Sunvitol E500, Delta Gold Tocotrienol

UNII Code: H4N855PNZ1

Group: Vitamin B9 (5-Methyltetrahydrofolate)

Also known as: Quatrefolic

Bee's Wax

animal part or source

Group: Beeswax

Group: Color

Also known as: FD&C Blue #1

Group: Vitamin D

Also known as: Vitamin D3

UNII Code: 1C6V77QF41

Group: Color

Group: Color

Folacin

vitamin

Group: Vitamin B9 (folic acid)

Also known as: Folic Acid

Folic Acid

vitamin

Group: Folate

Also known as: Orgen-FA, Vitamin B9, Quatrefolic, Folacin, CitraFolic, B9, Folate

UNII Code: 935E97BOY8

Gelatin

protein

Group: Gelatin

Group: Glycerol

Group: Hydrogenated Vegetable Oil

Group: Collagen

Also known as: Gelatin

life’s DHA

fatty acid

Group: DHA (Docosahexaenoic Acid)

Also known as: Docosahexaenoic Acid

Group: Vitamin B6 (pyridoxine)

Also known as: Vitamin B6

Group: Water

Quali-C

vitamin

Group: Vitamin C (ascorbic acid)

Also known as: Vitamin C

Quatrefolic

non-nutrient/non-botanical

Group: 5-methyltetrahydrofolate glucosamine

Also known as: (6S)-5-Methylfolate, (6S)-5-MTHF

UNII Code: Q65PL71Q1A

Group: lecithin

Group: Titanium Dioxide

Vitamin B9

vitamin

Group: Folate

Also known as: Folic Acid, Folate

UNII Code: 935E97BOY8

Product Statements

Formula re: Type

Rx prenatal vitamin & DHA

Formula re: Contains

With Quatrefolic(R)

General Statements: All Other Content

Rx Only

Brand IP Statement(s) re: (c), (TM), (SM)

DESCRIPTION: PRENATE DHA(R) 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.

Formula re: Type

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

Precautions re: All Other

CONTRAINDICATIONS: PRENATE DHA(R) is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Precautions re: All Other

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 know to have an inherited or acquired predisposition to bleeding.

Precautions re: All Other

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

Precautions re: Allergies

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or poison control center immediately. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Precautions re: Allergies

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

Suggested/Recommended/Usage/Directions

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

General Statements: All Other Content

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.

Brand IP Statement(s) re: (c), (TM), (SM)

Quatrefolic(R) is a registered trademark of Gnosis, SpA. Covered by one or more claims of U.S. Patent # 7,947,662 CAS# 1181972-37-1

Brand IP Statement(s) re: (c), (TM), (SM)

PRENATE ELITE(R) is a registered trademark of Acella Pharmaceuticals, LLC. Under license from Acella Pharmaceuticals, LLC. All rights reserved.

General: Product/Version Code

Rev. 021412

Precautions re: Pregnant or Nursing or Prescription Medications

Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those know to have an inherited or acquired predisposition to bleeding.

Storage

Store at 20(0) - 25(0)C (68(0) - 77(0)F); excursions permitted to 15(0) -30(0)C (59(0) - 86(0)F) [See USP Controlled Room Temperature.]

Formula re: Contains

PRENATE DHA(R) contains fish oil and soy.

Precautions re: Allergies

PRENATE DHA(R) contains fish oil and soy.

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