Reaphirm Plant Source DHA description, usages, side effects, indications, overdosage, supplying and lots more!

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Reaphirm Plant Source DHA

Everett Laboratories, Inc.
Everett Laboratories, Inc.

Product Information.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Contraindications

Reaphirm Plant Source DHA is contraindicated in patients with hypersensitivity to any of its components or color additives.

Folic acid is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to folic acid.

Iron Therapy is contraindicated in patients with hemochromatosis and patients with iron storage disease or the potential for iron storage disease due to chronic hemolytic anemia (e.g., inherited anomalies of hemoglobin structure or synthesis and/or red cell enzyme deficiencies, etc.), pyridoxine responsive anemia, or cirrhosis of the liver.

Cyanocobalamin is contraindicated in patients with sensitivity to cobalt or to cyanocobalamin (Vitamin B12).



Boxed Warning

WARNING: 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 a Poison Control Center immediately.

WARNINGS/PRECAUTIONS:

















Drug Interactions:













Information for Patients:

Pediatric Use:


Side Effects

Adverse reactions have been reported with specific vitamins and minerals, but generally at doses substantially higher than those in Reaphirm Plant Source DHA.  Reported adverse events include skin ailments, gastrointestinal complaints, glucose abnormalities, and visual problems.

Dosage and Administration

Before, during and after pregnancy, one softgel capsule daily, or as directed by a physician.

How Supplied

Reaphirm Plant Source DHA is available as a dark blue, oval shaped softgel capsule imprinted "EV3010".  Available in Box of Unit-Dose pack of 30 (5 child resistant blister cards of 6 softgel capsules).

Store at room temperature, approximately 15-30C (59-86F), avoid excessive heat.

Rx Only

Manufactured for

EVERETT LABORATORIES, INC.


West Orange, NJ 07052

1-877-324-9349

Principal Display Panel

reaphirm111128carton_lcr

Reaphirm Plant Source DHA

Reaphirm Plant Source DHA

Prenatal Supplement CAPSULE, GELATIN COATED

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:0642-3010
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
VITAMIN A 1100 [iU]
ASCORBIC ACID ASCORBIC ACID 30 mg
THIAMINE MONONITRATE THIAMINE ION 1.6 mg
RIBOFLAVIN RIBOFLAVIN 1.8 mg
NIACIN 15 mg
PYRIDOXINE HYDROCHLORIDE PYRIDOXINE 2.5 mg
Cyanocobalamin CYANOCOBALAMIN .012 mg
FOLIC ACID FOLIC ACID 1 mg
Iodine IODINE 0.150 mg
MAGNESIUM 20 mg
Zinc ZINC 25 mg
Copper COPPER 2 mg
Vitamin D 1000 [iU]
Omega-3 Fatty Acids 200 mg
Vitamin E VITAMIN E 20 [iU]
IRON IRON 29 mg

Inactive Ingredients

Ingredient Name Strength
GELATIN
sorbitol
GLYCERIN
SOYBEAN OIL
water
YELLOW WAX
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
LECITHIN, SOYBEAN
titanium dioxide
SODIUM THIOSULFATE
SUNFLOWER OIL
Tocopherol
ASCORBYL PALMITATE
CARAMEL
FD&C BLUE NO. 1
CORN OIL

Product Characteristics

Color Size Imprint Code Shape
blue (Dark Blue) 10 mm EV3010 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 6 in 1 BLISTER PACK
2 NDC:0642-3010-30 5 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2011-12-05


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