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  5. Label Information: Prenaissance

FDA Label for Prenaissance

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. DESCRIPTION:
    3. OTHER INGREDIENTS:
    4. INDICATIONS:
    5. CONTRAINDICATIONS:
    6. WARNING:
    7. BOXED WARNING
    8. PRECAUTIONS:
    9. ADVERSE REACTIONS:
    10. CAUTION:
    11. DOSAGE AND ADMINISTRATION:
    12. HOW SUPPLIED:
    13. PRINCIPAL DISPLAY PANEL - 30 SOFTGELS

Prenaissance Product Label

The following document was submitted to the FDA by the labeler of this product Acella Pharmaceuticals, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Rx Only

EACH SOFTGEL CONTAINS:

Vitamin C (ascorbic acid, USP)28 mg
Calcium (tricalcium phosphate, NF)160 mg
Iron (ferrous fumarate, USP)29 mg
Vitamin D3 (cholecalciferol, USP)800 IU
Vitamin E (d-alpha tocopherol, USP)30 IU
Vitamin B6 (pyridoxine HCl, USP)25 mg
Folic Acid, USP1.25 mg
DHA (docosahexaenoic acid)325 mg
Docusate Sodium, USP55 mg

All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. Please note: this is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendations based on each such person’s professional opinion and knowledge, upon evaluating the active ingredients, excipients, inactive ingredients and chemical information provided herein.

MANUFACTURED FOR:
Acella Pharmaceuticals, LLC
Alpharetta, GA 30009
1-800-541-4802

Rev. 0411


Description:



Prenaissance Capsules are a prescription prenatal/postnatal multivitamin/multimineral softgel capsule with DHA. Each softgel is brown in color, opaque and imprinted with “341” on one side.


Other Ingredients:



gelatin, glycerin, purified water, soybean oil, lecithin, yellow bees wax, natural creamy orange flavor, titanium dioxide, FD&C red #40, ethyl vanillin, FD&C yellow #5, FD&C blue #1.


Indications:



Prenaissance Capsules are a multivitamin/multimineral nutritional supplement with DHA indicated for use in the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation.


Contraindications:



This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Do not take this product if you are presently taking mineral oil, unless directed by a physician.


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.


Boxed Warning



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:



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.


Adverse Reactions:



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


Caution:



Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) daily.


Dosage And Administration:



Usual adult dose is 1 (one) softgel daily or as directed by a physician.


How Supplied:



Prenaissance Capsules are supplied in child-resistant bottles of 30 softgels (NDC# 42192-341-30).

Store at 20° - 25°C (68° - 77°F) [See USP].

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


Principal Display Panel - 30 Softgels



NDC 42192-341-30

Prenaissance Capsules

Rx Prenatal Vitamin and DHA

Rx only              30 Softgels

Acella
PHARMACEUTICALS, LLC

PRINCIPAL DISPLAY PANEL - 30 Softgels - 7240d5fb cb2d 4278 988f c8e6bba6560d 01

PRINCIPAL DISPLAY PANEL - 30 Softgels - 7240d5fb cb2d 4278 988f c8e6bba6560d 01


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