Tricare Prenatal 2-part Daily Prenatal Vitamin System
FDA Label NDC 67112-502

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medecor Pharma, Llc for the product Tricare Prenatal 2-part Daily Prenatal Vitamin System (NDC 67112-502). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding statement of identity, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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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