Prenate DHA

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.