Prenate DHA

All products:

• If you have an allergy to this medicine or any part of Prenate DHA.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have too much iron in your body.

Products with vitamin A:

• If you are taking acitretin.

Products with omega-3 fatty acids:

• If you are taking a blood thinner.
• If you have bleeding problems.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Prenate DHA with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Prenate DHA.
• If you have phenylketonuria (PKU), talk with your doctor. Some products have phenylalanine.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

All products:

• Follow how to take Prenate DHA as you have been told by your doctor. Do not use more than you were told to use.
• Some drugs may need to be taken with food or on an empty stomach. For some drugs it does not matter. Check with your pharmacist about how to take this medicine.
• Take with a full glass of water.
• Do not take antacids within 2 hours of Prenate DHA.
• Do not take dairy products with this medicine. Dairy products may make Prenate DHA not work as well.
• Follow the diet and workout plan that your doctor told you about.

Caplet:

• This medicine may be chewed or swallowed whole.

Chewable tablet:

• Chew well before swallowing.

Twist-off softgel:

• Twist the small end off from the softgel. Squeeze the contents right into your mouth or into juice to drink.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

Rx Only Dietary Supplement

DESCRIPTION: Prenate DHA® is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is blue in color, opaque, and imprinted with “301” on one side and blank on the other.

Prenate DHA® contains fish oil and soy.

OTHER INGREDIENTS: Bovine gelatin, glycerin, soy lecithin, soybean oil, white beeswax, purified water, FD&C Blue No. 1, titanium dioxide and FD&C Red No. 3.

INDICATIONS: Prenate 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.

CONTRAINDICATIONS: Prenate DHA® 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 in 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 (75854-312-30). 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.]

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.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Formical® is a registered trademark of Nephro-Tech 1, LLC, covered by one or more claims of U.S. Patent No. 6,528,542.

Sumalate® is a registered trademark of Albion Laboratories, Inc., covered by one or more claims of U.S. Patent Nos. 5,516,925, 6,716,814, 8,007,846, and 8,425,956.

PRENATE® is a registered trademark of Acella Pharmaceuticals, LLC. Under license from Acella Pharmaceuticals, LLC. All rights reserved.

MANUFACTURED FOR:
Avion Pharmaceuticals, LLC
Alpharetta, Georgia 30022
1-888-61-AVION

Rev. 0315

75854-312-30

Prenate DHA

Rx prenatal vitamin & DHA

• Key vitamins, minerals, and DHA support nutrition

GLUTEN FREE
Rx Only
Dietary Supplement

30 Softgels

AVION
PHARMACEUTICALS

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.