RELNATE DHA
RELNATE DHA
FULL PRESCRIBING INFORMATION: CONTENTS*
- Description
- RELNATE DHA INDICATIONS AND USAGE
- RELNATE DHA CONTRAINDICATIONS
- PRECAUTIONS
- WARNING
- DRUG INTERACTIONS
- ADVERSE REACTION
- RELNATE DHA DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
- PRINCIPAL DISPLAY PANEL - 30 Soft gel Bottle Label
FULL PRESCRIBING INFORMATION
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.
RELNATE DHA INDICATIONS AND USAGE
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.
RELNATE DHA 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 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 DHAOMEGA-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
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RELNATE DHAOMEGA-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
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