Prenatal Vitamin No 53 Iron Fum Folic Acid Docusate CA DHA
PRENATAL VITAMIN NO. 53/IRON FUM/FOLIC ACID/DOCUSATE CA/DHA(29 mg-1.25 mg-55 mg-350 mg)Contains Docusate CALCIUM
FULL PRESCRIBING INFORMATION: CONTENTS*
FULL PRESCRIBING INFORMATION
Softgels
Rx
DESCRIPTION: PRENATAL VITAMIN NO. 53/IRON FUM/FOLIC ACID/DOCUSATE CA/DHA (29 mg-1.25 mg-55 mg-350 mg) is an orally administered prescription prenatal/postnatal multivitamin/ mineral softgel with fish-based DHA. PRENATAL VITAMIN NO. 53/IRON FUM/FOLIC ACID/DOCUSATE CA/DHA (29 mg-1.25 mg-55 mg-350 mg) is available as opaque brown, oblong softgels imprinted “V251” and are available in 30-count bottles (NDC 76439-257-30).
| Each softgel contains: | |
|---|---|
| Vitamin C (ascorbic acid) | 28 mg |
| Vitamin D3 (cholecalciferol) | 800 IU |
| Vitamin E (d-alpha tocopherol) | 30 IU |
| Vitamin B6 (pyridoxine hydrochloride) | 25 mg |
| Folic Acid | 1.25 mg |
| Biotin | 250 mcg |
| Calcium | 160 mg |
| Iron (ferrous fumarate) | 29 mg |
| Omega oil blend | 660 mg |
| Docusate CALCIUM | 55 mg |
Other Ingredients: Annatto, Beeswax, Citric Acid, Ethyl Vanillin, Gelatin, Glycerin, Natural Creamy Orange Flavor, Purified Water, Soy Lecithin, Titanium Dioxide and other ancillary ingredients as needed to ensure product stability.
This product contains fish and/or algal and soy and has less than 1% EPA.
Note: This product does not contain Docusate Sodium but rather instead Docusate Calcium.
Uses
INDICATIONS: PRENATAL VITAMIN NO. 53/IRON FUM/FOLIC ACID/DOCUSATE CA/DHA (29 mg-1.25 mg-55 mg-350 mg) Softgels are indicated to provide vitamin/mineral and fish-based DHA supplementation throughout pregnancy, during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. PRENATAL VITAMIN NO. 53/IRON FUM/FOLIC ACID/DOCUSATE CA/DHA (29 mg-1.25 mg-55 mg-350 mg) Softgels may be useful in improving the nutritional status of women prior to conception.
CONTRAINDICATIONS: PRENATAL VITAMIN NO. 53/IRON FUM/FOLIC ACID/DOCUSATE CA/DHA (29 mg-1.25 mg-55 mg-350 mg) Softgels are contraindicated in patients with a known hypersensitivity to any of the ingredients. Do not take this product if you are presently taking mineral oil, unless directed by a healthcare practitioner.
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.
WARNING: Daily ingestion of more than 3 grams per day of omega-3 fatty acids (ALA, EPA, and DHA) may have potential antithrombotic activities, or effects, and may increase bleeding times. Administration of omega-3 fatty acids, including DHA, should be avoided in patients with inherited or acquired bleeding diathesis, including those taking anticoagulants. Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.
PRECAUTION: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 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.
ALLERGY STATEMENT: This product has been manufactured in a facility that also manufactures products containing tree nuts, peanuts, fish, egg, wheat, milk, soy and shellfish. Individuals with allergic tendencies to these substances should use discretion.
CAUTION: Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.
DOSAGE AND ADMINISTRATION: Before, during and/or after pregnancy, one softgel daily or as directed by a licensed healthcare practitioner.
HOW SUPPLIED: PRENATAL VITAMIN NO. 53/IRON FUM/FOLIC ACID/DOCUSATE CA/DHA (29 mg-1.25 mg-55 mg-350 mg) is available as opaque brown, oblong softgels imprinted “V251” and are available in 30-count bottles (NDC 76439-257-30).
KEEP OUT OF REACH OF CHILDREN.
This product may - under certain circumstances, be dispensed through a certified mail-order program so long as there is record of prescription AND confirmation that the patient is under licensed medical supervision. This product is not an Orange Book (OB) rated product, therefore all prescriptions using this product shall be pursuant to state statutes as applicable.
Call your medical practitioner about side effects. You may also report side effects to Virtus Pharmaceuticals, LLC at 813-283-1344.
Store at 20 – 25°C (68 – 77°F). [See USP Controlled Room Temperature.]
Dispense in a tight, light resistant container. Protect from light and moisture.
Manufactured for:
Virtus Pharmaceuticals, LLC
Tampa, FL. 33619
Made in Canada Rev. 4/2014
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 76439-257-30
PRENATAL VITAMIN NO. 53/
IRON FUM/FOLIC ACID/
DOCUSATE CA/DHA
(29 mg-1.25 mg-55 mg-350 mg)
Contains Docusate CALCIUM
Rx Prenatal Vitamin with omega oil providing DHA
Essential vitamin and minerals
Gentle stool softener
Softgels
Rx 30 Softgels
Prenatal Vitamin No 53 Iron Fum Folic Acid Docusate CA DHA- ascorbic acid, cholecalciferol, .alpha.-tocopherol, d-, pyridoxine hydrochloride, folic acid, biotin, calcium, ferrous fumarate, omega-3 fatty acids and docusate capsule, gelatin CAPSULE, GELATIN COATED
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
