PNV DHA

Basic Information

Product Label

Full Name: PNV DHA

Brand: Acella Pharmaceuticals none

Product Type: Other Combinations

Physical State: Softgel Capsule

Product Version Code: Rev. 0418-05

Contact Information

Manufactured for

Name: Acella Pharmaceuticals, LLC

Address:Alpharetta, GA, 30005

Phone: 1-800-541-4802

Types: Distributor

Product Details

Net Contents

30 Softgel(s)(30 Softgel(s))

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

Amount: 140 mg

Serving Size: 1 Softgel(s)

Adults and children 4 or more years of age: 14%

Pregnant and Lactating: 11%

Group: Calcium

Docosahexaenoic Acid

fatty acid

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

Amount: 300 mg

Serving Size: 1 Softgel(s)

Adults and children 4 or more years of age: % (Daily Value (DV) Not Established)

Pregnant and Lactating: % (Daily Value (DV) Not Established)

Group: DHA (Docosahexaenoic Acid)

Also known as: DHA

Folate

vitamin

Notes: Folate (Form: as (6S)-N5-Methyltetrahydrofolic Acid Calcium Salt Note: equivalent to 600 mcg of folic acid)

Forms:

as (6S)-N5-Methyltetrahydrofolic Acid Calcium Salt

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: 27 mg

Serving Size: 1 Softgel(s)

Adults and children 4 or more years of age: 150%

Pregnant and Lactating: 150%

Group: Iron

Magnesium

mineral

Notes: Magnesium (Form: as Magnesium Oxide)

Forms:

as Magnesium Oxide

Amount: 45 mg

Serving Size: 1 Softgel(s)

Adults and children 4 or more years of age: 11%

Pregnant and Lactating: 10%

Group: Magnesium

Vitamin B12

vitamin

Notes: Vitamin B12 (Form: as Cyanocobalamin)

Forms:

Cyanocobalamin

Amount: 12 mcg

Serving Size: 1 Softgel(s)

Adults and children 4 or more years of age: 200%

Pregnant and Lactating: 150%

Group: Vitamin B12

UNII Code: 8406EY2OQA

Vitamin B6

vitamin

Notes: Vitamin B6 (Form: as Pyridoxine HCl)

Forms:

Pyridoxine Hydrochloride

Amount: 25 mg

Serving Size: 1 Softgel(s)

Adults and children 4 or more years of age: 1250%

Pregnant and Lactating: 1000%

Group: Vitamin B6

Vitamin C

vitamin

Forms:

Ascorbic Acid

Amount: 85 mg

Serving Size: 1 Softgel(s)

Pregnant and Lactating: 142%

Adults and children 4 or more years of age: 142%

Group: Vitamin C (unspecified)

Vitamin D3

vitamin

Forms:

Cholecalciferol

Amount: 200 IU

Serving Size: 1 Softgel(s)

Pregnant and Lactating: 50%

Adults and children 4 or more years of age: 50%

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 Acetate)

Forms:

DL-Alpha-Tocopherol Acetate

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

Bovine Gelatin

protein

Group: Gelatin

Cholecalciferol

vitamin

Group: Vitamin D

Also known as: Vitamin D3

UNII Code: 1C6V77QF41

FD&C Blue No. 1

other

Group: Color

FD&C Red No. 3

other

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

Glycerin

other

Group: Glycerol

life’s DHA

fatty acid

Group: DHA (Docosahexaenoic Acid)

Also known as: Docosahexaenoic Acid

organic Pyridoxine

vitamin

Group: Vitamin B6 (pyridoxine)

Also known as: Vitamin B6

purified Water

other

Group: Water

Quali-C

vitamin

Group: Vitamin C (ascorbic acid)

Also known as: Vitamin C

Soy Lecithin

fat

Group: lecithin

Titanium Dioxide

other

Group: Titanium Dioxide

Vegetable Shortening

fat

Group: Vegetable Oil (unspecified)

Vitamin B9

vitamin

Group: Folate

Also known as: Folic Acid, Folate

UNII Code: 935E97BOY8

White Beeswax

animal part or source

Group: Beeswax

Product Statements

FDA Statement of Identity

Rx Only Dietary Supplement

FDA Statement of Identity

Description: PNV-DHA is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is cobalt blue in color, opaque, and imprinted with "BP321" on one side and blank on the other. PNV-DHA can also be beneficial in improving the nutritional status of women prior to conception.

Precautions re: Allergies

PNV-DHA contains fish oil and soy.

Formula re: Type

Indications: PNV-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.

Precautions re: All Other

Contraindications: PNV-DHA is contraindicated in patients with a known hypersensivity 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).

Precautions re: Pregnant or Nursing or Prescription Medications

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

Precautions re: All Other

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.

Precautions re: Children

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.

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: Bottles of 30 softgels (42192-321-30). The listed product number is not a National Drug Code. Instead, Acella 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

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