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  5. Label Information: Tricare Prenatal 2-part Daily Prenatal Vitamin System

FDA Label for Tricare Prenatal 2-part Daily Prenatal Vitamin System

View Indications, Usage & Precautions

Table of Contents

    1. STATEMENT OF IDENTITY
    2. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tricare Prenatal 2-part Daily Prenatal Vitamin System Product Label

The following document was submitted to the FDA by the labeler of this product Medecor Pharma, 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.

Statement Of Identity



INDICATIONS AND USAGE: TriCare Prenatal™ Chewable
Tablets with Twist-off DHA Softgels are indicated to provide
vitamin and mineral supplementation throughout
pregnancy and during the postnatal period for both the
lactating and non-lactating mother. It is also useful for
improving nutritional status prior to conception.
CONTRAINDICATIONS: This product is contraindicated in
patients with a known hypersensitivity to any of the
ingredients.
NOTICE: Contact with moisture may produce surface
discoloration or erosion of the tablets and twist-off softgels.
ADVERSE REACTIONS: Allergic sensitization has been
reported following both oral and parenteral administration
of folic acid.
DOSAGE: Two (2) chewable tablets and two (2) twist-off
softgels daily or as directed by a physician.
ADMINISTRATION: Chew tablets before swallowing. Twist
small end off from softgel and squeeze contents directly into
mouth or into juice to drink. Daily dosage should be taken
with food.
HOW SUPPLIED: Child-resistant, blister pack of two (2) white
tablets and two (2) purple twist-off softgels.
Each tablet is embossed MP 201.
Each Twist-off softgel is marked MP 802.
(NDC 67112-502-60)
Store at controlled room temperature, 15°-30°C (59°-86°F).
TO REPORT a serious adverse event or obtain product
information, call 877-803-8235.
KEEP THIS AND ALL DRUGS OUT OF THE REACH
OF CHILDREN.
Marketed by: Medecor Pharma, LLC, Baton Rouge, LA
Patent Pending


Package Label.Principal Display Panel




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