RE OB 90 DHA

Generic Name: multivitamin, multi-mineral nutritional supplement
Dosage Form: softgel capsule

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

RE OB 90 + DHA

DESCRIPTION:

RE OB 90 + DHA is a high-potency, multivitamin, multi-mineral nutritional supplement with DHA (Omega-3 Fatty Acid).


Other Ingredients (RE OB 90 + DHA caplet):
Calcium Carbonate, Carmine Powder, Croscarmellose Sodium, Crospovidone, Gelatin, Hydrogenated Soybean Oil, Hydroxypropyl Methylcellulose, Magnesium Stearate, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Polysorbate 80, Povidone, Red Cabbage, Silicon Dioxide, Starch, Stearic Acid, Sucrose, Talc, Titanium Dioxide, Triacetin.

Each RE OB 90 + DHA softgel contains:



Other Ingredients (RE OB 90 +DHA softgel): Gelatin, Water, Glycerin, Polysorbate 80.

May contain Vanillin.

Also contains Eicosapentaenoic Acid (EPA) and other Omega-3 Fatty Acids (from tuna oil).

Cloudiness of the softgel capsule is a characteristic of natural fish oil.

Contains Soy.

Contains NO artificial flavors or preservatives, yeast, wheat, gluten, nuts or milk-based by-products.

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.

RE OB 90 + DHA supplies important prenatal vitamins, minerals and nutrients to supplement the nutritional needs of women, before, during and after pregnancy. Deficiencies of these nutrients are common during pregnancy and lactation and should be prescribed by a physician prior to conception.

RE OB 90 + DHA caplet is manufactured in a drug-certified cGMP (current good manufacturing practices) facility and meets or exceeds USP standards for potency, purity and dissolution. RE OB 90 + DHA softgel complies with the most stringent worldwide standards for fish oil and is manufactured in a NSF Certified cGMP Facility.

INDICATIONS AND USAGE:

RE OB 90 + DHA is a prescription regimen of prenatal multivitamin, multi-mineral and omega-3 fatty acid supplements indicated for use in improving the nutritional status of women throughout pregnancy and in the post-natal period for both lactating and non-lactating mothers. RE OB 90 + DHA is also useful in improving the nutritional status prior to conception.

DOSAGE AND ADMINISTRATION:

Before, during and after pregnancy, one caplet and one softgel taken by mouth daily, or as prescribed by a physician. The caplet and softgel may be taken together or at different times of the day. Caution should be exercised to ensure that the prescribed dose of DHA does not exceed one gram (1,000 mg) per day.

CONTRAINDICATIONS:

RE OB 90 + DHA is contraindicated in patients with a known hypersensitivity to any of the ingredients, including fish oil and soy. Iron is contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemias. This product is contraindicated for persons with pernicious anemia, as folic acid may obscure its signs and symptoms.

Slideshow: View Frightful (But Dead Serious) Drug Side Effects

WARNING:

Folic acid alone is improper therapy in the treatment of pernicious anemia in that hematological remission can occur while neurological manifestations remain progressive.

Ingestion of omega-3 fatty acids (including alpha-linolenic acid [ALA], eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA] from fish oils) of more than 3 grams per day may present antithrombotic effects, including increased bleeding time. Omega-3 fatty acids including DHA and EPA should be avoided in patients with inherited or acquired bleeding diatheses. Patients taking anticoagulant drug products should consult with their physician prior to ingesting omega-3 fatty acids.

PRECAUTIONS:

Folic acid in dosages above 400 mcg daily may obscure megaloblastic (pernicious) anemia in that hematological remission can occur while neurological manifestations (Addisonian anemia) remain progressive.

ADVERSE REACTIONS:

Iron: Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) can occur but are usually mild and can subside with continuation of therapy. Although the absorption of iron is best when taken between meals, RE OB 90 + DHA when taken after meals, may control occasional G.I. disturbances. RE OB 90 + DHA is best absorbed when taken at bedtime.

Allergic sensitizations have been reported following both oral and parenteral administration of folic acid. Caution should be exercised with patients with known allergies to fish or fish byproducts.

Call your doctor for medical advice about side effects. You may report suspected side effects to the FDA at 1-800-FDA-1088.

USE IN SPECIFIC POPULATIONS:

RE OB 90 + DHA is not advocated for pediatric or geriatric use.

OVERDOSE:

Iron: Signs and Symptoms: Iron is toxic. Acute overdosage of iron may cause nausea and vomiting. In severe cases, iron overdose can cause cardiovascular collapse and death. Other symptoms include pallor and cyanosis, melena, shock, drowsiness and coma. The estimated overdose of orally ingested iron is 300mg/kg body weight. When overdoses are ingested by children, severe reactions, including fatalities have resulted. RE OB 90 + DHA should be stored beyond the reach of children to prevent against accidental iron poisoning. Keep this and all other drugs out of reach of children. Treatment: For specific therapy, exchange transfusion and chelating agents should be used. For general management, perform gastric lavage with sodium bicarbonate solution or milk. Administer intravenous fluids and electrolytes and use oxygen.

HOW SUPPLIED:

RE OB 90 + DHA (NDC 68032-338-60) is a 30-day regimen supplied as one bottle containing 30 dark purple RE OB 90 + DHA Prenatal capsule shaped caplets NDC: 68032-494-30 imprinted “RE 338” and one bottle containing 30 pale yellow DHA softgel capsules NDC: 68032-495-30. Dispense in tight, light-resistant containers as defined in the USP/NF with child resistant closures. Store at controlled room temperature 15°-30°C (59°-86°F). Keep in a cool, dry place.

CAUTION: Rx Only

Manufactured for:
River’s Edge
Pharmaceuticals, LLC
Iss. 07/10
338-12

PACKAGING:

RE OB 90 DHA 
ascorbic acid, calcium citrate, iron pentacarbonyl, cholecalciferol, alpha-tocopherol, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, potassium iodide, zinc oxide, cupric oxide, docusate sodium, doconexent kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68032-338
Packaging
# Item Code Package Description
1 NDC:68032-338-60 1 KIT (KIT) in 1 CARTON
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE 30 
Part 2 1 BOTTLE 30 
Part 1 of 2
RE OB 90 DHA PRENATAL MULTIVITAMIN AND MINERALS 
ascorbic acid, calcium citrate, iron pentacarbonyl, cholecalciferol, alpha-tocopherol, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, potassium iodide, zinc oxide, cupric oxide, docusate sodium tablet
Product Information
Item Code (Source) NDC:68032-494    
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 120 mg
CALCIUM CITRATE (CALCIUM) CALCIUM CITRATE 200 mg
IRON PENTACARBONYL (IRON) IRON PENTACARBONYL 90 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]
ALPHA-TOCOPHEROL (ALPHA-TOCOPHEROL) ALPHA-TOCOPHEROL 30 [iU]
THIAMINE HYDROCHLORIDE (THIAMINE) THIAMINE HYDROCHLORIDE 3 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3.4 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 20 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 20 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
POTASSIUM IODIDE (POTASSIUM CATION) POTASSIUM IODIDE 150 ug
ZINC OXIDE (ZINC) ZINC OXIDE 25 mg
CUPRIC OXIDE (CUPRIC OXIDE) CUPRIC OXIDE 2 mg
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 50 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM CARBONATE  
CROSCARMELLOSE SODIUM  
CROSPOVIDONE  
GELATIN  
HYDROGENATED SOYBEAN OIL  
HYPROMELLOSE 2208 (100 MPA.S)  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
POLYDEXTROSE  
POLYETHYLENE GLYCOL  
POLYSORBATE 80  
POVIDONE  
CABBAGE  
SILICON DIOXIDE  
STARCH, CORN  
STEARIC ACID  
SUCROSE  
TALC  
TITANIUM DIOXIDE  
TRIACETIN  
Product Characteristics
Color purple Score no score
Shape CAPSULE Size 20mm
Flavor Imprint Code RE;338
Contains         
Packaging
# Item Code Package Description
1 NDC:68032-494-30 30 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 10/01/2008 11/30/2012
Part 2 of 2
RE OB 90 DHA DOCOSAHEXAENOIC ACID CAPSULE 
doconexent capsule
Product Information
Item Code (Source) NDC:68032-495    
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCONEXENT (DOCONEXENT) DOCONEXENT 250 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN  
WATER  
GLYCERIN  
POLYSORBATE 80  
Product Characteristics
Color yellow Score no score
Shape CAPSULE Size 20mm
Flavor Imprint Code RE;338
Contains         
Packaging
# Item Code Package Description
1 NDC:68032-495-30 30 CAPSULE (CAPSULE) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 10/01/2008 11/30/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 10/01/2008 11/30/2012
Labeler - River's Edge Pharmaceuticals, LLC (133879135)
Revised: 04/2010
 
River's Edge Pharmaceuticals, LLC



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