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  5. Label Information: Prenatal Vitamins Plus Low Iron

FDA Label for Prenatal Vitamins Plus Low Iron

View Indications, Usage & Precautions

Table of Contents

    1. BOXED WARNING
    2. DESCRIPTION
    3. INDICATIONS & USAGE
    4. DOSAGE & ADMINISTRATION
    5. CONTRAINDICATIONS
    6. PRECAUTIONS
    7. STORAGE AND HANDLING
    8. HOW SUPPLIED
    9. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Prenatal Vitamins Plus Low Iron Product Label

The following document was submitted to the FDA by the labeler of this product Remedyrepack Inc.. 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.

Boxed Warning



DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under six. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN. In case of accidental overdose, call a physician or Poison Control Center immediately.


Description



Each Tablet Contains:Amount
Per Tablet 		% Daily
Value
Vitamin A (from Acetate and Beta Carotene)4000 IU80%
Vitamin C (Ascorbic Acid)120 mg200%
Vitamin D-3 (Cholecalciferol)400 IU100%
Vitamin E (dl-Alpha Tocopheryl Acetate)22 mg73%
Vitamin B-1(Thiamine Mononitrate)1.84 mg123%
Vitamin B-2 (Riboflavin)3 mg176%
Niacin (as Niacinamide)20 mg100%
Vitamin B-6 (Pyridoxine HCI)10 mg500%
Folic Acid1 mg200%
Vitamin B-12 (Cyanocobalamin)12 mcg200%
Calcium (from Calcium Carbonate)200 mg20%
Iron (Ferrous Fumarate)27 mg150%
Zinc (Zinc Oxide)25mg167%
Copper (Cupric Oxide)2 mg100%

Other Ingredients: Ascorbyl Palmitate, Citric Acid anhydrous, DL- alpha Tocopherol, Ethylcellulose, FD&C Blue #2 lake, FD&C Red #40 lake, FD&C Yellow #6 lake, Glucose, Gum Acacia, Hypromellose, Magnesium Stearate, Maize Starch, Maltodextrin, Methylcellulose, Microcrystalline Cellulose, Mineral Oil, Mono and di-glycerides, Polyethylene Glycol, Pregelatinzed Corn Starch, Silicon Dioxide, Sorbic Acid, Soy Protein, Stearic Acid, Sucrose, Titanium Dioxide, Tricalcium Phosphate.


Indications & Usage



Indications: To provide Vitamin and Mineral supplementation throughout pregnancy and during the postnatal period for both the lactating and nonlactating mother. It is also useful for improving nutritional status prior to conception.


Dosage & Administration



Directions: Before, during and after pregnancy, one tablet daily or as directed by a physician.


Contraindications



Contraindications: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.


Precautions



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


Package Label.Principal Display Panel



DRUG: Prenatal Vitamins Plus Low Iron

GENERIC: Prenatal with Ferrous Fum and Folic Acid

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-2746-0

COLOR: brown

SHAPE: OVAL

SCORE: No score

SIZE: 9 mm

IMPRINT: P;5

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • VITAMIN A ACETATE 3080[iU] in 1
  • BETA CAROTENE 920[iU] in 1
  • ASCORBIC ACID 120mg in 1
  • CHOLECALCIFEROL 400[iU] in 1
  • .ALPHA.-TOCOPHEROL ACETATE, DL- 22mg 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 CARBONATE 200mg in 1
  • IRON 27mg in 1
  • ZINC 25mg in 1
  • COPPER 2mg in 1

    • INACTIVE INGREDIENT(S):

    • TRICALCIUM PHOSPHATE
    • SUCROSE
    • STEARIC ACID
    • SOY PROTEIN
    • SORBIC ACID
    • SILICON DIOXIDE
    • POLYETHYLENE GLYCOL, UNSPECIFIED
    • GLYCERYL MONOSTEARATE
    • MINERAL OIL
    • MICROCRYSTALLINE CELLULOSE
    • METHYLCELLULOSE (100 MPA.S)
    • TITANIUM DIOXIDE
    • MALTODEXTRIN
    • MAGNESIUM STEARATE
    • HYPROMELLOSE, UNSPECIFIED
    • ACACIA
    • DEXTROSE, UNSPECIFIED FORM
    • FD&C YELLOW NO. 6
    • FD&C RED NO. 40
    • FD&C BLUE NO. 2
    • ETHYLCELLULOSE, UNSPECIFIED
    • .ALPHA.-TOCOPHEROL, DL-
    • ANHYDROUS CITRIC ACID
    • STARCH, CORN
    • ASCORBYL PALMITATE


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