M-natal Plus Tablet
FDA Label NDC 70518-3579

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Remedyrepack Inc. for the product M-natal Plus (NDC 70518-3579). 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 description, dosage and administration, warning:, caution, how supplied, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Description

M-Natal Plus Tablet is an orally administered prenatal/postnatal prescription folic acid-containing dietary supplement and should be administered under the supervision of a licensed medical practitioner.

Dosage And Administration

Before, during and/or after pregnancy, one tablet daily, with a meal, or as directed by a licensed healthcare practitioner regardless of lactation status.

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.

Caution

High levels of folic acid may, especially in older adults, hide signs of Vitamin B-12 deficiency (such as pernicious anemia), a condition that can cause nerve damage.

Store at 15° – 30°C (59° – 86°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container. Notice: Contact with moisture may produce surface discoloration or erosion.

Call your licensed medical practitioner about side effects. You may report side effects by calling Method at 1-877-250-3427 or FDA at 1-800-FDA-1088.

How Supplied

Supplied as beige tablet, imprinted "M170" dispensed in

NDC: 70518-3579-00

PACKAGING: 30 in 1 BLISTER PACK

Store at 15° – 30°C (59° – 86°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container. Notice: Contact with moisture may produce surface discoloration or erosion.

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Package Label.Principal Display Panel

DRUG: M-Natal Plus

GENERIC: Vitamin A, Vitamin C, Vitamin D, Vitamin E, Thiamine, Riboflavin, Niacin, Vitamin B6, Folic Acid, Vitamin B12, Calcium, Iron, Zinc, Copper

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-3579-0

COLOR: brown

SHAPE: RECTANGLE

SCORE: No score

SIZE: 19 mm

IMPRINT: M170

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • VITAMIN A 4000[iU] in 1
  • ASCORBIC ACID 120mg in 1
  • VITAMIN D 400[iU] in 1
  • .ALPHA.-TOCOPHEROL ACETATE 22[iU] in 1
  • THIAMINE 1.84mg in 1
  • RIBOFLAVIN 3mg in 1
  • NIACIN 20mg in 1
  • PYRIDOXINE HYDROCHLORIDE 10mg in 1
  • FOLIC ACID 1mg in 1
  • CYANOCOBALAMIN 12ug in 1
  • CALCIUM 200mg in 1
  • FERROUS FUMARATE 27mg in 1
  • ZINC 25mg in 1
  • COPPER 2mg in 1

    • INACTIVE INGREDIENT(S):

    • MICROCRYSTALLINE CELLULOSE
    • CROSCARMELLOSE SODIUM
    • POLYVINYL ALCOHOL, UNSPECIFIED
    • STEARIC ACID
    • TITANIUM DIOXIDE
    • POLYETHYLENE GLYCOL, UNSPECIFIED
    • TALC
    • MAGNESIUM STEARATE
    • SILICON DIOXIDE
    • CARAMEL
    • CARNAUBA WAX

      • Remedy_label (Remedy Label)

      Remedy_label (Remedy Label)

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