CitraNatal Rx description, usages, side effects, indications, overdosage, supplying and lots more!

CitraNatal Rx

Mission Pharmacal Company
Mission Pharmacal Company

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
CitraNatal R

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.

DESCRIPTION

CitraNatal® Rx is a scored white oval multivitamin/multimineral tablet. The tablet is debossed “CN RX” on one side and is blank on the other.

Each tablet contains:
Vitamin C (Ascorbic acid) 120 mg
Calcium (Calcium citrate) 125 mg
Iron (Carbonyl iron, ferrous gluconate) 27 mg
Vitamin D3 (Cholecalciferol) 400 IU
Vitamin E (dl-alpha tocopheryl acetate) 30 IU
Thiamin (Vitamin B1) 3 mg
Riboflavin (Vitamin B2) 3.4 mg
Niacinamide (Vitamin B3) 20 mg
Vitamin B6 (Pyridoxine) 20 mg
Folic Acid 1 mg
Iodine (Potassium iodide) 150 mcg
Zinc (Zinc oxide) 25 mg
Copper (Cupric oxide) 2 mg
Docusate Sodium 50 mg

INDICATIONS

CitraNatal® Rx is a multivitamin/multimineral prescription drug indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers.

CONTRAINDICATIONS

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

WARNING

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.

NOTICE: Contact with moisture can produce surface discoloration or erosion of the tablet.

PRECAUTIONS

Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

ADVERSE REACTIONS

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

DOSAGE AND ADMINISTRATION

One tablet daily or as directed by a physician. DISPENSE IN A TIGHT, LIGHT RESISTANT CONTAINER AS DEFINED BY THE USP/NF WITH A CHILD RESISTANT CLOSURE. Store at controlled room temperature.

L085990

C02 Rev 005080


MISSION PHARMACAL COMPANY
San Antonio, TX USA 78230 1355

CitraNatal® Rx Label
NDC: 0178-0859-90

CitraNatal Rx

Vitamin C, Calcium, Iron, Vitamin D3, Vitamin E, Thiamin, Riboflavin, Niacinamide, Vitamin B6, Folic Acid, Iodine, Zinc, Copper, Docusate Sodium TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:0178-0859
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ASCORBIC ACID ASCORBIC ACID 120 mg
CALCIUM CITRATE CALCIUM CATION 125 mg
IRON IRON 27 mg
Vitamin D 400 [iU]
.ALPHA.-TOCOPHEROL ACETATE 30 [iU]
Thiamine 3 mg
RIBOFLAVIN RIBOFLAVIN 3.4 mg
NIACINAMIDE 20 mg
PYRIDOXINE HYDROCHLORIDE PYRIDOXINE 20 mg
FOLIC ACID FOLIC ACID 1 mg
Potassium Iodide IODIDE ION 150 mg
Zinc Oxide Zinc oxide 25 mg
CUPRIC OXIDE CUPRIC CATION 2 mg
DOCUSATE SODIUM DOCUSATE 50 mg

Inactive Ingredients

Ingredient Name Strength
POVIDONES
FERROUS GLUCONATE
ALPHA-TOCOPHERYLQUINONE
magnesium silicate
POLYETHYLENE GLYCOLS
ETHYL VANILLIN

Product Characteristics

Color Size Imprint Code Shape
WHITE 10 mm CN;RX OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0178-0859-90 90 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2007-11-26


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