FDA records indicate that there are no current recalls for this drug.
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Side Effects & Adverse Reactions
WARNING: Pernicious anemia should be ruled out before starting treatment. While folic acid corrects the blood picture of pernicious anemia, it does not ameliorate the attendant neurologic involvement. Resistance to treatment may be due to depressed hematopoiesis, alcoholism, the presence of anti-metabolic drugs and to deficiencies of vitamins. Prolonged use of iron salts may produce iron storage disease.
Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or bleeding diathesis, individuals who have or suspected that they may have iron metabolism abnormalities should use caution in using supplemental iron. Iron supplementation in these individuals may lead to excess iron in the parenchyma of many organs. Iron storage and associated organ function tests may be indicated to ensure the delivery of needed iron to the neonate while ensuring the health of the mother.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
INDICATIONS: PNV - OB with DHA is indicated to provide vitamin, mineral and omega-3 fatty acid supplementation prior to conception, throughout pregnancy and during the postnatal period for the lactating and non-lactating mother, including individuals with known allergies to fish. PNV - OB with DHA does not contain fish, fish oils, fish proteins or fish byproducts.
History
There is currently no drug history available for this drug.
Other Information
SUPPLEMENT FACTS
Each tablet contains:
A (beta carotene) | 2700 IU |
D (cholecalciferol) | 400 IU |
C (ascorbic acid) | 70 mg |
E (dl-alpha tocopheryl acetate) | 30 IU |
Folic Acid | 1 mg |
B1 (thiamine mononitrate) | 1.6 mg |
B2 (riboflavin) | 1.8 mg |
B6 (pyridoxine hydrochloride) | 2.5 mg |
B12 (cyanocobalamin) | 12 mcg |
Niacin (niacinamide) | 18 mg |
Calcium (calcium carbonate) | 100 mg |
Elemental Iron (ferrous fumerate) | 65 mg |
Magnesium (magnesium oxide) | 25 mg |
Zinc (zinc oxide) | 25 mg |
Copper (copper oxide) | 2 mg |
Each softgel capsule contains: | |
Docosahexaenoic Acid (DHA) | 250 mg |
Lauric Acid | 20 mg |
OTHER INGREDIENTS (softgel): bovine gelatin, glycerin USP and water.
OTHER INGREDIENTS (tablet): dicalcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, stearic acid and silicon dioxide,
Sources
Pnv-ob-dha Manufacturers
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Acella Pharmaceuticals, Llc
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