Prenate Elite

Formula re: Type

INDICATIONS: PRENATE ELITE(R) is a multivitamin/multimineral 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 ELITE(R) can also be 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: Children

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.

Suggested/Recommended/Usage/Directions

DOSAGE AND ADMINISTRATION: One tablet daily or as directed by a physician.

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.

Formula re: Type

PRENATAL VITAMINS-FILM COATED TABLETS

Formula re: Contains

With Quatrefolic(R)

General Statements: All Other Content

Rx Only

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

DESCRIPTION: PRENATE ELITE(R) is a white, oval, oil- and water-soluble, multivitamin/multimineral, film-coated tablet debossed with "PN" on one side and blank on the other.

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 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

Precautions re: Allergies

ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

General Statements: All Other Content

HOW SUPPLIED: PRENATE ELITE(R) is supplied in child-resistant bottles of 90 tablets (75854-301-90). 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.

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.]

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

General: Product/Version Code

Rev. 022012