PreferaOB One

Basic Information

Product Label

Product label for PreferaOB One
Full Name: PreferaOB One
Brand: Alaven Pharmaceutical ®
Product Type: Other Combinations
Physical State: Softgel Capsule
Status: Off Market
Product Version Code: CL6-086-00-01-1209a

Contact Information

Manufactured for

Name: Alaven(R) Pharmaceutical LLC
Address:Marietta, GA, 30062
Website: www.PreferaOB.com
Types: Distributor

For medical inquiries call toll free

Phone: 1-888-317-0001
Types: Other

Product Details

Net Contents

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

Serving Sizes

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

Target Groups

Pregnant WomenAdult Female (18 - 50 Years)Lactating

Ingredients & Nutrition

Biotin

vitamin
Amount: 30 mcg
Serving Size: 1 Tablet(s)

Group: Biotin

Also known as: Vitamin H, Vitamin B-7, Vitamin B7, d-biotin, S. cerevisiae

UNII Code: 6SO6U10H04

Amount: 200 mg
Serving Size: 1 Tablet(s)

Group: DHA (Docosahexaenoic Acid)

Also known as: DHA

Folic Acid

vitamin
Amount: 1 mg
Serving Size: 1 Tablet(s)

Group: Folate

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

UNII Code: 935E97BOY8

Iodine

mineral

Notes: Iodine (Form: as Potassium Iodide)

Forms:
  • as Potassium Iodide
Amount: 175 mcg
Serving Size: 1 Tablet(s)

Group: Iodine

Iron

mineral
Amount: 0 NP
Serving Size: 1 Tablet(s)

Group: Iron

Notes: Vitamin B12 (Form: as Cyanocobalamin)

Forms:
  • Cyanocobalamin
Amount: 12 mcg
Serving Size: 1 Tablet(s)

Group: Vitamin B12

UNII Code: 8406EY2OQA

Vitamin B3

vitamin

Notes: Vitamin B3 (Form: Niacin, as Niacinamide)

Forms:
  • Niacin
  • Niacinamide
Amount: 17 mg
Serving Size: 1 Tablet(s)

Group: Niacin

Also known as: IP-6

UNII Code: 2679MF687A

Vitamin B5

vitamin

Notes: Vitamin B5 (Form: as D-Calcium Pantothenate)

Forms:
  • D-Calcium Pantothenate
Amount: 10 mg
Serving Size: 1 Tablet(s)

Group: Vitamin B5

Also known as: Pantothenic Acid

UNII Code: 19F5HK2737

Vitamin B6

vitamin

Notes: Vitamin B6 (Form: as Pyridoxine HCl)

Forms:
  • Pyridoxine Hydrochloride
Amount: 50 mg
Serving Size: 1 Tablet(s)

Group: Vitamin B6

Vitamin C

vitamin
Forms:
  • Ascorbic Acid
Amount: 25 mg
Serving Size: 1 Tablet(s)

Group: Vitamin C (unspecified)

Vitamin D3

vitamin
Forms:
  • Cholecalciferol
Amount: 400 IU
Serving Size: 1 Tablet(s)

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 Tocopheryl Acetate)

Forms:
  • DL-Alpha-Tocopheryl Acetate
Amount: 10 IU
Serving Size: 1 Tablet(s)

Group: Vitamin E

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

UNII Code: H4N855PNZ1

Zinc

mineral

Notes: Zinc (Form: as Zinc Oxide)

Forms:
  • Zinc Oxide
Amount: 15 mg
Serving Size: 1 Tablet(s)

Group: Zinc

Group: Vitamin D

Also known as: Vitamin D3

UNII Code: 1C6V77QF41

Folacin

vitamin

Group: Vitamin B9 (folic acid)

Also known as: Folic Acid

Gelatin

protein

Group: Gelatin

Group: Collagen

Also known as: Gelatin

Group: lecithin

life’s DHA

fatty acid

Group: DHA (Docosahexaenoic Acid)

Also known as: Docosahexaenoic Acid

Group: Vitamin B3 (Niacin)

Also known as: Vitamin B3

UNII Code: 2679MF687A

Group: Vitamin B5 (Pantothenic Acid)

Also known as: Vitamin B5

Group: Vitamin B6 (pyridoxine)

Also known as: Vitamin B6

Quali-C

vitamin

Group: Vitamin C (ascorbic acid)

Also known as: Vitamin C

Group: Soybean Oil

Vitamin H

vitamin

Group: Vitamin B7 (biotin)

Also known as: Biotin

UNII Code: 6SO6U10H04

yellow Beeswax

animal part or source

Group: Beeswax

Product Statements

General Statements: All Other Content

Rx Only

General Statements: All Other Content

NDC 68220-086-30

General Statements: All Other Content

The Prenatal YOU CAN COUNT ON!

Formula re: Contains

FIRST and ONLY prenatal with Natural, Body-Ready HEME Iron + DHA in an all-in-one softgel 12 Essential Vitamins and Minerals including: - High dose of vitamin B6 - 1mg of folic acid Plus Plant-based life'sDHA(TM) Omega-3

FDA Statement of Identity

Pre/Post-natal Nutritional Supplement + DHA

Seals/Symbols

life'sDHA(TM) HEALTHY BRAIN, EYES, HEART

Formula re: Type

Prenatal/Postnatal Multivitamin/Multimineral/DHA softgel

Formula re: Contains

DESCRIPTION: PreferaOB ONE(TM) is a prescription prenatal/postnatal multivitamin/multimineral nutritional supplement with Omega-3 fatty acid (life'sDHA(TM)1).

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

PreferaOB ONE(TM) is an oblong shaped, opaque purple colored softgel, imprinted "AP 86" in white ink on one side and plain on the other.

General Statements: All Other Content

DHA is derived from the oils of microalgae, which is grown outside of the ocean, in a controlled environment, eliminating the risk of oceanic contamination.

Formula re: Type

INDICATIONS AND USAGE PreferaOB ONE(TM) is a prescription multivitamin/multimineral nutritional supplement with Omega-3 fatty acid (life'sDHA(TM)) indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and non-lactating mothers. PreferaOB ONE(TM) is also beneficial in improving the nutritional status of women prior to conception.

Precautions re: All Other

CONTRAINDICATIONS This product 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 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 or acquired predisposition to bleeding diathesis.

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: All Other

PRECAUTIONS Folic acid when administered as a single agent in doses above 0.1 mg daily may obscure pernicious anemia in that hematological remission can occur while neurological manifestations remain progressive.

Precautions re: Pregnant or Nursing or Prescription Medications

Pregnant women and nursing mothers should avoid supplemental doses of vitamin E higher than RDA amounts. While prescribing this nutritional supplement for pregnant women, nursing mothers, or for women prior to conception, their medical condition and other drugs, herbs, and/or supplements consumption should be considered.

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 One softgel daily with or without food, or as prescribed by a licensed health care provider with prescribing authority.

General Statements: All Other Content

HOW SUPPLIED PreferaOB ONE(TM) is supplied in child-resistant blister packs of 30 softgels (NDC 68220-086-30) and as a Professional Sample (NDC 68220-086-25).

Precautions re: Children

KEEP OUT OF REACH OF CHILDREN.

Storage

STORAGE Store at controlled room temperature 20(0)-25(0)C (68(0)-77(0)F). Excursions permitted to 15(0)-30(0)C (59(0)-86(0)F). [See current USP] To protect from light, dispense in carton provided. Once open, blisters should be stored in carton.

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

U.S. Patent No. 7,585,527 life'sDHA(TM) is a trademark of Martek Biosciences Corporation, Columbia, MD. Proferrin(R) is a registered trademark of Colorado Biolabs, Inc , Cozad, NE. PreferaOB(R) is a registered trademark and PreferaOB ONE(TM) is a trademark of Alaven(R) Pharmaceutical LLC, Marietta, GA.

General: Product/Version Code

CL6-086-00-01-1209a

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