CitraNatal Assure
CitraNatal Assure Rx Prenatal Vitamin Tablet and 300 mg DHA Capsule
06c529fc-272c-f889-f5e5-7f3e5ef2c59d
HUMAN PRESCRIPTION DRUG LABEL
Jan 8, 2024
Mission Pharmacal Company
DUNS: 008117095
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ascorbic acid, calcium citrate, iron, vitamin d, dl- alpha- tocopherol acetate, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, iodine, zinc, copper, docusate sodium, doconexent and icosapent
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Retail
Carton
BOXED WARNING SECTION
WARNING
Accidental overdose ofiron-containingproducts 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.
INDICATIONS & USAGE SECTION
INDICATIONS
CitraNatal Assure ®is a multivitamin/mineral 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 SECTION
CONTRAINDICATIONS
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
ADVERSE REACTIONS SECTION
ADVERSE REACTIONS
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
DOSAGE & ADMINISTRATION SECTION
DOSAGE AND ADMINISTRATION
One tablet and one capsule daily or as directed by a physician.
STORAGE AND HANDLING SECTION
STORAGE
Store at 20–25°C (68–77°F)
NOTICE
Contact with moisture can discolor or erode the tablet.
HOW SUPPLIED SECTION
Six child-resistant blister packs of 5 tablets and 5 capsules each - NDC 0178-0891-30
SPL UNCLASSIFIED SECTION
To report a serious adverse event or obtain product information, call (210) 696-8400.
51062R1120
MISSION ®PHARMACAL
DHA capsules manufactured for:
MISSION PHARMACAL COMPANY
San Antonio, TX USA 78230 1355
Prenatal tablets manufactured by:
MISSION PHARMACAL COMPANY
San Antonio, TX USA 78230 1355
Copyright © 2020 Mission Pharmacal Company.
All rights reserved.
WARNINGS SECTION
WARNING
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B 12is deficient.
PRECAUTIONS SECTION
PRECAUTIONS
Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.
DESCRIPTION SECTION
DESCRIPTION
CitraNatal Assure ®is a prescription prenatal/postnatal multivitamin/mineral tablet with Ferr-Ease ®, a patented dual-iron delivery comprising both a quick release and slow release iron, and a capsule of an essential fatty acid. The prenatal vitamin is a white, coated, oval multivitamin/mineral tablet. The tablet is debossed "0891" on one side and is blank on the other. The essential fatty acid DHA capsule is caramel colored and contains a light yellow to orange semi-solid mixture.
|
Each prenatal capsule contains: | ||
|
Vitamin C (Ascorbic acid) |
120 |
mg |
|
Calcium (Calcium citrate) |
124 |
mg |
|
Iron (Carbonyl iron, ferrous gluconate) |
35 |
mg |
|
Vitamin D 3(Cholecalciferol) |
400 |
IU |
|
Vitamin E (dl-alpha tocopheryl acetate) |
30 |
IU |
|
Thiamin (Vitamin B 1) |
3 |
mg |
|
Riboflavin (Vitamin B 2) |
3.4 |
mg |
|
Niacinamide (Vitamin B 3) |
20 |
mg |
|
Vitamin B 6(Pyridoxine HCl) |
25 |
mg |
|
Folic Acid |
1 |
mg |
|
Iodine (Potassium iodide) |
150 |
mcg |
|
Zinc (Zinc oxide) |
25 |
mg |
|
Copper (Cupric oxide) |
2 |
mg |
|
Docusate Sodium |
50 |
mg |
|
Each DHA gelatin capsule contains: | ||
|
Docosahexaenoic Acid (DHA, 40% from 750 mg Algal Oil) |
300 |
mg |
|
Eicosapentaenoic Acid (EPA) |
Not more than 0.750 |
mg |
Other ingredients in DHA gelatin capsule: Gelatin, sunflower oil, glycerin, caramel color, sunflower lecithin, rosemary extract, tocopherols, ascorbyl palmitate.