Relnate DHA

Generic Name: omega-3 fatty acids, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, folic acid, cholecalciferol, ascorbic acid, alpha-tocopherol, cupric sulfate anhydrous, zinc oxide, iron and magnesium
Dosage Form: capsule, liquid filled

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.

RELNATE
DHA

PRENATAL / MULTIVITAMIN

Rev. 3/11

Softgels
Omega-3
  Fatty Acids (DHA-EPA)
200mg
Vitamin B1
  (Thiamine Mononitrate)
3 mg
Vitamin B2
  (Riboflavin)
3 mg
Vitamin B6
  (Pyridoxine HCL)
20 mg
Vitamin B12
  (Cyanocobalamin)
15 mcg
Folic Acid 1 mg
Vitamin D3
  (Cholecalciferol)
400 IU
Vitamin C
  (Ascorbic Acid)
100 IU
Vitamin E
  (d-alpha tocopherol)
30 IU
Mineral Copper
  (Sulfate)
1 mg
Zinc
  (Zinc Oxide)
20 mg
Iron
  (Fumerate)
28 mg
Magnesium 30 mg

Rx ONLY

Description

Each Softgel Contains:

Omega-3
  Fatty Acids (DHA-EPA)
200mg
Vitamin B1
  (Thiamine Mononitrate)
3 mg
Vitamin B2
  (Riboflavin)
3 mg
Vitamin B6
  (Pyridoxine HCL)
20 mg
Vitamin B12
  (Cyanocobalamin)
15 mcg
Folic Acid 1 mg
Vitamin D3
  (Cholecalciferol)
400 IU
Vitamin C
  (Ascorbic Acid)
100 IU
Vitamin E
  (d-alpha tocopherol)
30 IU
Mineral Copper
  (Sulfate)
1 mg
Zinc
  (Zinc Oxide)
20 mg
Iron
  (Fumerate)
28 mg
Magnesium 30 mg

INACTIVE INGREDIENTS

Gelatin, Glycerine, purified water, annatto extract, lecithin, yellow beeswax, titanium dioxide.

Slideshow: OTC Medication Use In Pregnancy: Wise or Worrisome?

Indications and Usage for Relnate DHA

Relnate DHA is a prescription multivitamin/multimineral indicated for use in improving the nutritional status of woman prior to conception, throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers.

Contraindications

Relnate DHA should not be used by patients with known history of hypersensitivity to any of the listed ingredients.

Precautions

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 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

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.

PEDIACTRIC USE

Safety and effectiveness in pediactric patients has not been established.

GERIACTRIC USE

No clinical studies have been performed in patients over 65 to determine whether older persons respond differently from younger persons. Physicians should consider that elderly person may have decreased hepatic, renal, or cardiac function.

Drug Interactions

Relnate DHA softgels are not recommended for and should not be given to patients receiving levodopa because the action of levodopa is antagonized by pyridoxine.

ADVERSE REACTION

Adverse reactions have been reported with specific vitamins and minerals but generally at levels substantially higher than those contained herein. However, allergic and idiosyncratic reactions are possible at lower levels. Iron, even at the usual recommended levels, has been associated with gastrointestinal intolerance in some patients.

Relnate DHA Dosage and Administration

Usual adult dose: one softgel daily or as prescribed by your doctor.

How is Relnate DHA Supplied

Relnate DHA is available as a Annato colored softgel, imprinted PRE 01. Available in 30 count bottles with NDC #35573-103-30 and sample cartons with NDC #35573-103-05.

NDC # 35573-103-05 PHYSICIAN SAMPLE NOT FOR RESALE

Recommended Storage 59-86 degrees (F). Protect from light moisture and avoid excessive heat. Dispense original carton.

KEEP OUT OF REACH OF CHILDREN

RX ONLY

BUREL
PHARMACEUTICALS
JACKSON, MS 39218

PRINCIPAL DISPLAY PANEL - 30 Soft gel Bottle Label

NDC 35573-200-30

Relnate
DHA

Omega-3 Fatty Acids (DHA-EPA) 200 mg
Vitamin B1 (Thiamine Mononitrate) 3 mg
Vitamin B2 (Riboflavin) 3 mg
Vitamin B6 (Pyridoxine HCL) 20 mg
Vitamin B12 (Cyanocobalamin) 15 mcg
Folic Acid 1 mg
Vitamin D3 (Cholecalciferol) 400 IU
Vitamin C (Ascorbic Acid) 100 mg
Vitamin E (d-alpha tocopherol) 30 IU
Copper (Cupric Sulfate) 1 mg
Zinc (Zinc Oxide) 20 mg
Iron (Fumerate) 28 mg
Magnesium 30 mg

Rx Only

Net Contents: 30 Soft gels

Relnate DHA 
omega-3 fatty acids, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, folic acid, cholecalciferol, ascorbic acid, alpha-tocopherol, cupric sulfate anhydrous, zinc oxide, iron, and magnesium capsule, liquid filled
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:35573-103
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OMEGA-3 FATTY ACIDS (OMEGA-3 FATTY ACIDS) OMEGA-3 FATTY ACIDS 200 mg
THIAMINE MONONITRATE (THIAMINE) THIAMINE MONONITRATE 3 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 20 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 15 ug
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 100 mg
ALPHA-TOCOPHEROL (ALPHA-TOCOPHEROL) ALPHA-TOCOPHEROL 30 [iU]
CUPRIC SULFATE ANHYDROUS (SULFATE ION) CUPRIC SULFATE ANHYDROUS 1 mg
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 20 mg
IRON (IRON) IRON 28 mg
MAGNESIUM (MAGNESIUM) MAGNESIUM 30 mg
Inactive Ingredients
Ingredient Name Strength
Gelatin  
Glycerin  
Water  
Bixa Orellana Seed  
Yellow Wax  
Titanium Dioxide  
Product Characteristics
Color RED (Annato colored) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code PRE;01
Contains         
Packaging
# Item Code Package Description
1 NDC:35573-103-05 1 BOTTLE (BOTTLE) in 1 CARTON
1 NDC:35573-103-30 30 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 05/15/2011
Relnate DHA 
omega-3 fatty acids, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, folic acid, cholecalciferol, ascorbic acid, alpha-tocopherol, cupric sulfate anhydrous, zinc oxide, iron, and magnesium capsule, liquid filled
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:35573-200
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OMEGA-3 FATTY ACIDS (OMEGA-3 FATTY ACIDS) OMEGA-3 FATTY ACIDS 200 mg
THIAMINE MONONITRATE (THIAMINE) THIAMINE MONONITRATE 3 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 20 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 15 ug
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 100 [iU]
ALPHA-TOCOPHEROL (ALPHA-TOCOPHEROL) ALPHA-TOCOPHEROL 30 [iU]
CUPRIC SULFATE ANHYDROUS (SULFATE ION) CUPRIC SULFATE ANHYDROUS 1 mg
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 20 mg
IRON (IRON) IRON 28 mg
MAGNESIUM (MAGNESIUM) MAGNESIUM 30 mg
Inactive Ingredients
Ingredient Name Strength
Gelatin  
Glycerin  
Water  
Bixa Orellana Seed  
Yellow Wax  
Titanium Dioxide  
Product Characteristics
Color RED (Annato colored) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code PRE;01
Contains         
Packaging
# Item Code Package Description
1 NDC:35573-200-30 30 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 05/15/2011
Labeler - Burel Pharmaceuticals, LLC (002152814)
Revised: 05/2011
 
Burel Pharmaceuticals, LLC



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