Prenatal Plus Vitamins Tablet
FDA Label NDC 70518-4258

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 Prenatal Plus Vitamins (NDC 70518-4258). 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, directions, caution, warning, storage, other, 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

Supplement Facts
Serving Size: 1 TabletAmount per Serving% Daily Value

Daily Value is for Pregnant and Lactating Women

Vitamin A1200 mcg92%
(Acetate and Beta Carotene)RAE
Vitamin C (Ascorbic Acid)120 mg100%
Vitamin D-3 (Cholecalciferol)10 mcg67%
Vitamin E (dl-α Tocopheryl Acetate)10 mg53%
Vitamin B-1 (Thiamine Mononitrate)1.84 mg131%
Vitamin B-2 (Riboflavin)3 mg188%
Niacin (Niacinamide)20 mg111%
Vitamin B-6 (Pyridoxine HCl)10 mg500%
Folic Acid1667 mcg278%
DFE (1 mg)
Vitamin B-12 (Cyanocobalamin)12 mcg429%
Calcium (Calcium Carbonate)200 mg15%
Iron (Ferrous Fumarate)27 mg100%
Zinc (Zinc Oxide)25 mg192%
Copper(Cupric Oxide)2 mg154%

Other Ingredients:Hypromellose, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Polyethylene Glycol, Stearic Acid, Titanium Dioxide, FD&C Blue #2 lake, FD&C Red #40 lake, FD&C Yellow #6 lake

Prenatal Plus Vitamins is a prescription folic acid containing dietary vitamin and mineral supplement for women before, during and after pregnancy.

Directions

Use before, during and after pregnancy under the supervision of a medical professional. One tablet daily or as prescribed.

Caution

Folic acid may partially correct the hematological damage due to Vitamin B-12 deficiency of pernicious anemia while the associated neurological damage progresses.

Warning

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under six. Keep this product out of the reach of children. In case of accidental overdose, call a Physician or Poison Control Center immediately.

Storage

Store at room temperature, USP. Protect from light and moisture.Dispense in a tight, light-resistant container. Contact with moisture may discolor or erode tablets.

Package Label.Principal Display Panel

DRUG: Prenatal Plus Vitamins

GENERIC: prenatal with ferrous fumarate and folic acid

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-4258-0

COLOR: brown

SHAPE: OVAL

SCORE: No score

SIZE: 9 mm

IMPRINT: P;5

PACKAGING: 100 in 1 BOTTLE, PLASTIC

ACTIVE INGREDIENT(S):

  • Vitamin A Acetate 924ug in 1
  • Beta Carotene 276ug in 1
  • Ascorbic Acid 120mg in 1
  • Cholecalciferol 10ug in 1
  • .Alpha.-TocopheroL Acetate, DL- 10mg in 1
  • Thiamine Mononitrate 1.84mg in 1
  • Riboflavin 3mg in 1
  • Niacinamide 20mg in 1
  • Pyridoxine Hydrochloride 10mg in 1
  • Folic Acid 1667ug in 1
  • Cyanocobalamin 12ug in 1
  • Calcium Carbonate 200mg in 1
  • Ferrous Fumarate 27mg in 1
  • Zinc Oxide 25mg in 1
  • Cupric Oxide 2mg in 1

    • INACTIVE INGREDIENT(S):

    • Hypromellose, Unspecified
    • Magnesium Stearate
    • Maltodextrin
    • Microcrystalline Cellulose
    • Polyethylene Glycol 400
    • Stearic Acid
    • Titanium Dioxide
    • FD&C Blue NO. 2
    • FD&C Red NO. 40
    • FD&C Yellow NO. 6

      • Remedy_label (Remedy Label)

      Remedy_label (Remedy Label)

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