Natelle One

Name: Natelle One

Natelle One Description

Natelle® One capsules for oral administration are supplied as oblong red soft gelatin capsules, imprinted with "Natelle1" in white ink.

Each capsule contains:

Docosahexaenoic Acid (DHA) from Algal Oil..................................250 mg

Eicosapentaenoic Acid (EPA).................................Not more than 0.625mg

Calcium (Tricalcium Phosphate).......................................................102 mg

Iron (Ferrous Fumarate) ...................................................................28 mg

Vitamin C (Ascorbic Acid) ...............................................................30 mg

Vitamin B-6 (Pyridoxine HCl) ...........................................................25 mg

Vitamin E (D-Alpha Tocopherol) ......................................................30 IU

Folic Acid ..........................................................................................1 mg

DHA is an omega-3 fatty acid. 250 mg of DHA from 625 mg of algal oil is derived from Crypthecodinium cohnii. 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.

Inactive Ingredients: Gelatin (Bovine), Beeswax, Glycerine, Soybean Oil, Lecithin, Titanium Dioxide, Ethyl Vanillin.

INDICATIONS and USAGE

Natelle® One is indicated to provide vitamin/mineral and DHA omega–3 fatty acid supplementation to women throughout pregnancy, during the postnatal period for both lactating and non–lactating mothers, and throughout the childbearing years. Natelle® One may be beneficial in improving the nutritional status of women prior to conception.

Warnings

Ingestion of more than 3 grams of omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including increased bleeding time and INR. Administration of omega-3 fatty acids should be avoided in patients on anticoagulants and in those known to have an inherited or acquired bleeding diathesis.

DOSAGE and ADMINISTRATION

One capsule daily, or as directed by a physician.

Principal display panel - bottle label

30 CAPSULES    NDC 0037-6072-30

natelle®ONE

Rx Prenatal Vitamin &Plant-Based DHA.
Now with 28 mg Iron

Rx Only

Distributed by:
MEDA
PHARMACEUTICALS™
Somerset, New Jersey 08873-4120

© 2013 Meda Pharmaceuticals Inc.

To report SUSPECTED ADVERSE REACTIONS,
contact Meda Pharmaceuticals Inc. at
1-877-999-8405 or 1-800-FDA-1088 or
www.fda.gov/medwatch.

NATELLE is a registered trademark and MEDA PHARMACEUTICALS and the MEDA PHARMACEUTICALS logo are trademarks of Meda AB or a related entity.

life’sDHA™ is a trademark of Martek Biosciences Corporation.

Natelle One 
doconexent, icosapent, calcium, iron, ascorbic acid, pyridoxine, .alpha.-tocopherol, folic acid capsule, gelatin coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0037-6072
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCONEXENT (DOCONEXENT) DOCONEXENT 250 mg
ICOSAPENT (ICOSAPENT) ICOSAPENT 0.625 mg
CALCIUM (CALCIUM) CALCIUM 102 mg
IRON (IRON) IRON 28 mg
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 30 mg
PYRIDOXINE (PYRIDOXINE) PYRIDOXINE 25 mg
.ALPHA.-TOCOPHEROL (.ALPHA.-TOCOPHEROL) .ALPHA.-TOCOPHEROL 30 [iU]
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN  
YELLOW WAX  
GLYCERIN  
SOYBEAN OIL  
LECITHIN, SOYBEAN  
TITANIUM DIOXIDE  
Product Characteristics
Color RED Score no score
Shape CAPSULE Size 25mm
Flavor Imprint Code natelle1
Contains     
Packaging
# Item Code Package Description
1 NDC:0037-6072-30 30 CAPSULE, GELATIN COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 02/01/2015
Labeler - MEDA Pharmaceuticals (051229602)
Revised: 05/2015   MEDA Pharmaceuticals

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Black, tarry, or bloody stools.
  • Fever.
  • Very upset stomach or throwing up.
  • Very bad belly pain.
  • Throwing up blood or throw up that looks like coffee grounds.
  • Stomach cramps.
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